Calendar · pharmadog

Sign In Subscribe

Week of Mar 31, 2025

50

Apr 2, 2025recall503d agoQuVa Pharma, Inc. recall (Cls II)IGC Pharma, Inc.

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Apr 2, 2025recall503d agoStrides Pharma, Inc. recall (Cls II)Strides Pharma Inc

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 — Reason: Presence of foreign substance: Presence of Benzene. — Status: Ongoing

full page →fda recalls ↗

Apr 2, 2025device 510k503d agoOrthocell, Ltd. — Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) (510k cleared)

Product code: JXI. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoIcu Medical, Inc. — Plum Duo Precision IV Pump (510k cleared)ICU MEDICAL INC/DE

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

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoDeka Research & Development Corp. — twiist system (510k cleared)

Product code: QFG. Advisory committee: Clinical Chemistry. Type: Special

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoSmith & Nephew, Inc. — LEGION Total Knee System (510k cleared)SMITH & NEPHEW PLC

Product code: JWH. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoOsteoremedies, LLC — SPECTRUM GV Bone Cement (510k cleared)

Product code: LOD. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoIcu Medical, Inc. — Plum Solo Precision IV Pump (510k cleared)ICU MEDICAL INC/DE

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

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoProsum Medical Limited — Small Volume 0.2mL Syringe (510k cleared)

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

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoStepone Fertility Ltd (T/A Béa Fertility) — Béa Applicator (BAP-GB-01) (510k cleared)

Product code: HDR. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoHi-D Imaging AG — Hi-D Imaging 4TAVR (510k cleared)

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

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoSeaSpine Orthopedics Corporation — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (510k cleared)

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

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoProgenix, LLC — Progenix Select Stim (510k cleared)

Product code: NUH. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoOlympus Corporations of the Americas — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (510k cleared)

Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoBiocircuit Technologies, Inc. — Nerve Wrap (07-DW-001-TAB) (510k cleared)BWX Technologies, Inc.

Product code: JXI. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoGynesonics, Inc. — Sonata Transcervical Fibroid Ablation System 2.2 (510k cleared)

Product code: KNF. Advisory committee: Obstetrics/Gynecology. Type: Special

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoIcu Medical, Inc. — LifeShield Infusion Safety Software Suite (510k cleared)ICU MEDICAL INC/DE

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

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoNvision Biomedical Technologies, Inc. — SnapHammer Hammertoe Correction System (510k cleared)

Product code: HWC. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoAsahi Intecc Co., Ltd. — SION blue PLUS (510k cleared)

Product code: DQX. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Apr 2, 2025device 510k503d agoShenzhen TPH Technology Co., Ltd. — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

full page →fda device 510k ↗

Apr 3, 2025approval502d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Apr 3, 2025approval502d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Apr 3, 2025approval502d agoUPLIZNA (INEBILIZUMAB-CDON) — FDA approvalHorizon Therapeutics USA Inc

Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 3, 2025device 510k502d agoSiemens Healthcare GmbH — syngo Dynamics (Version VA41D) (510k cleared)

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

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoFresenius Medical Care Renal Therapies Group, LLC — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch (510k cleared)Fresenius Medical Care AG

Product code: KDJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoCarbon (Shenzhen) Medical Device Co., Ltd. — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoShina Med Corporation — SureFine Pen Needle (510k cleared)

Product code: FMI. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoBeaver-Visitec International, Inc. — Leos Laser and Endoscopy System (510k cleared)

Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor 2.5-3.5 mm (510k cleared)

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

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoXsto Co., Ltd. — Powered wheelchair (mobility robot) (M4, M4U) (510k cleared)

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

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoStaclear, Inc. — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (510k cleared)

Product code: QLY. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoSpine Wave, Inc. — Salvo® Robotic Navigation Instruments (510k cleared)

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

full page →fda device 510k ↗

Apr 3, 2025device 510k502d agoMasimo Corporation — Masimo W1 (510k cleared)MASIMO CORP

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

full page →fda device 510k ↗

Apr 4, 2025approval501d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

Apr 4, 2025approval501d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗

Apr 4, 2025approval501d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

Apr 4, 2025approval501d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

Apr 4, 2025approval501d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 4, 2025approval501d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

Apr 4, 2025device 510k501d agoBiotronik, Inc. — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (510k cleared)

Product code: LIT. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoNingbo Dechang Electrical Machinery Made Co.,Ltd — LED Light Therapy Mask (RT01) (510k cleared)

Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoPhilips Medical Systems Nederland B.V. — Philips VSC-MEDlib (510k cleared)

Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoTerumo Europe N.V. — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoHighridge Medical, LLC — Virage® OCT Spinal Fixation System (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoWuhan Pioon Technology Co., Ltd. — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoTurbett Surgical — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Viral Transport Medium (510k cleared)Hangzhou DAC Biotech Co Ltd

Product code: JSM. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

Apr 4, 2025device 510k501d agoPrapela, Inc. — Prapela SVS hospital bassinet pad (model P01) (510k cleared)

Product code: QVY. Advisory committee: General Hospital. Type: Direct

full page →fda device 510k ↗

page 17 of 433