Calendar · pharmadog

Sign In Subscribe

Week of Dec 1, 2025

50

Dec 3, 2025device pma259d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 3, 2025device pma259d agoMedtronic, Inc. — Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 3, 2025device pma259d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 3, 2025device pma259d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (PMA)

Product code: MTF. Advisory committee: IM. Decision: APPR

full page →fda device pma ↗

Dec 3, 2025device pma259d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 3, 2025device pma259d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 3, 2025device pma259d agoMedtronic, Inc. — Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips Healthcare (Suzhou) Co., Ltd. device recall (Cls II)

Philips Incisive CT — Reason: Potential for incomplete scan due to unstable connection inside of floating sensor. — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoCareFusion 303, Inc. device recall (Cls II)

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products. — Reason: Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoMedtronic Neuromodulation device recall (Cls II)

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900). — Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal — Reason: Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal. — Status: Ongoing

full page →fda device recalls ↗

Dec 3, 2025device recall259d agoPhilips North America device recall (Cls II)

Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025approval258d agoEPLERENONE — FDA approvalEPLERENONE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →EPLERENONE →fda approvals ↗

Dec 4, 2025approval258d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Dec 4, 2025device 510k258d agoVektor Medical, Inc. — Vektor Computational ECG Mapping System (vMap®) (510k cleared)VYCOR MEDICAL INC

Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoAsustek Computer, Inc. — ASUS Ultrasound Imaging System (LU800 series) (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoNp Medical — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (510k cleared)

Product code: FPA. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoChawla Heart Technologies, LLC — MitraPatch Mitral Valve Repair System (510k cleared)

Product code: PAW. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (510k cleared)Dawn Sea Therapeutics

Product code: JNL. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoSc Medica — FFX Facet Fixation System (510k cleared)

Product code: MRW. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoTigon Medical — Tigon Medical Knotless and Dual Javelin All-Suture Anchors (510k cleared)

Product code: MBI. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoZhejiang Taotao Vehicle Co., Ltd. — Mobility Scooter (T5) (510k cleared)

Product code: INI. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k258d agoSpineology, Inc. — Spineology Navigation Instruments (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗

Dec 4, 2025device pma258d agoBausch and Lomb, Inc., — Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses (PMA supplement)

Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗

Dec 4, 2025device pma258d agoPhysio-Control, Inc. — LIFEPAK® 35 Defibrillator/monitor (PMA supplement)

Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 4, 2025device pma258d agoLenstec, Inc. — Softec HD; Softec I; Softec HDO; Softec HDM (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: HQL. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Dec 4, 2025device pma258d agoLenstec, Inc. — ClearView 3 (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MFK. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Dec 4, 2025device pma258d agoCordis US Corporation — S.M.A.R.T.® CONTROL® Nitinol Stent System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 4, 2025device pma258d agoCordis US Corporation — S.M.A.R.T. and S.M.A.R.T.® CONTROL® Vascular Stent Systems (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Allwell Inflation Device, for angiographic use REF: IS-30-A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Manifold Kit REF: K09-13203A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMobius Imaging, LLC device recall (Cls II)

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. — Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMobius Imaging, LLC device recall (Cls II)

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. — Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall258d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Allwell Angioplasty Pack REF: IS-30-B1/B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

page 35 of 275