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12,945 catalysts · 3,392 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
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12,945 catalysts · 3,392 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
Philips Incisive CT — Reason: Potential for incomplete scan due to unstable connection inside of floating sensor. — Status: Ongoing
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: PAW. Advisory committee: Cardiovascular. Type: Traditional
Product code: JNL. Advisory committee: Immunology. Type: Traditional
Product code: MRW. Advisory committee: Unknown. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: HQL. Advisory committee: OP. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MFK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Allwell Inflation Device, for angiographic use REF: IS-30-A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
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
Merit Medical , Custom Manifold Kit REF: K09-13203A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
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
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
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
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
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
Allwell Angioplasty Pack REF: IS-30-B1/B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090 — Reason: Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. — Status: Ongoing
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. — Reason: Device packaged in incorrect outer box carton. — Status: Ongoing
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A — Reason: Due to probe bags that may have a compromised or incomplete sterile pouch seal. — Status: Ongoing
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL