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Week of Mar 10, 2025

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Mar 12, 2025recall520d agoSafecor Health, LLC recall (Cls II)

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025recall520d agoZydus Pharmaceuticals (USA) Inc recall (Cls II)LB PHARMACEUTICALS INC

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing

full page →fda recalls ↗

Mar 12, 2025device 510k520d agoRewalk Robotics Ltd. Dba Lifeward — ReWalk® 7 Personal Exoskeleton (50-20-0005) (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoCutting Edge Spine, LLC — EVOL® ha Hyper C Cervical Interbody Fusion System (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoShenzhen Zuowei Technology Co., Ltd. — Walking rehabilitation training electric wheelchair (ZW518) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoQuantalx Neroscience — Delphi Amplifier (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoChangsha Anxiang Medical Technology Co., Ltd. — Wireless TENS & EMS Unit (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoRay Co., Ltd. — RCT600 (510k cleared)Ray Therapeutics Inc

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoRayence Co., Ltd. — 2430TCA with Xmaru W (510k cleared)

Product code: MUE. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoWontech Co., Ltd. — PICOALEX (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoDannik, LLC — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (510k cleared)

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

full page →fda device 510k ↗

Mar 12, 2025device 510k520d agoBiofire Defense, LLC — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (510k cleared)Dawn Sea Therapeutics

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

full page →fda device 510k ↗

Mar 13, 2025approval519d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 13, 2025approval519d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

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Mar 13, 2025approval519d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL

full page →ACETAZOLAMIDE →fda approvals ↗

Mar 13, 2025approval519d agoARBLI (LOSARTAN POTASSIUM) — FDA approvalLOSARTAN POTASSIUM

Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Mar 13, 2025approval519d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

full page →TYENNE →fda approvals ↗

Mar 13, 2025approval519d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 13, 2025approval519d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Mar 13, 2025approval519d agoMEROPENEM — FDA approvalHQ Speciality Pharma

Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION

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Mar 13, 2025approval519d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →PYZCHIVA →fda approvals ↗

Mar 13, 2025approval519d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PYZCHIVA →fda approvals ↗

Mar 13, 2025approval519d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Mar 13, 2025approval519d agoBUCAPSOL (BUSPIRONE HYDROCHLORIDE) — FDA approvalBUSPIRONE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL

full page →BUSPIRONE HYDROCHLORIDE →fda approvals ↗

Mar 13, 2025device 510k519d agoBioserenity Medical Devices Group — IceCap product line (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoBoston Aesthetics, Inc. — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoMedcad — MedCAD® AccuStride System (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoMY01, Inc. — MY01 Continuous Compartmental Pressure Monitor (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoZiehm Imaging GmbH — Ziehm Vision FD (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoSioxmed, LLC — SiOxC Cream (510k cleared)

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

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Mar 13, 2025device 510k519d agoCryosurgery, Inc. — CryoFreeze Wart and Skin Tag Remover (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoXemis Medical Technology (Shenzhen) Co., Ltd. — Photon Therapy Apparatus (BL-10) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoMaxx Orthopedics, Inc. — Freedom Total Knee System (All-poly Tibial Plate) (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoInari Medical, Inc. — FlowTriever2 Catheter (510k cleared)Mobia Medical, Inc.

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoG.N.S Neolaser , Ltd. — neoLaser Laser Surgery Fibers (510k cleared)

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

full page →fda device 510k ↗

Mar 13, 2025device 510k519d agoSpectranetics — Turbo-Elite Laser Atherectomy Catheter (510k cleared)

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

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Mar 14, 2025approval518d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Mar 14, 2025device 510k518d agoOrthoPediatrics Corp. — VerteGlide Spinal Growth Guidance System (510k cleared)ORTHOPEDIATRICS CORP

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

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoAion Biosystems, Inc. — AION TempShield (510k cleared)NED Biosystems Inc

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

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoShenzhen Sanping Image Technology Co., Ltd. — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) (510k cleared)

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoDosisoft SA — PLANET Onco Dose (3.2) (510k cleared)

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

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoCenters for Disease Control and Prevention — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (510k cleared)Hubei Provincial Center for Disease Control and Prevention

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

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Mar 14, 2025device 510k518d agoNexxt Spine — NEXXT MATRIXX® SI System (510k cleared)

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

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoArrow International, LLC (A subsidiary of Teleflex, Inc.) — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) (510k cleared)Arrow International LLC

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

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoAidite (Qinhuangdao) Technology Co., Ltd. — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (510k cleared)

Product code: EIH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoKettenbach GmbH & Co. KG — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (510k cleared)

Product code: EBF. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoKorot Co., Ltd. — KOROT Blood Pressure Monitor (KOROT P3 Accurate) (510k cleared)Kowa Co Ltd

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

full page →fda device 510k ↗

Mar 14, 2025device 510k518d agoLumea, Inc. — Viewer+ (510k cleared)

Product code: QKQ. Advisory committee: Pathology. Type: Traditional

full page →fda device 510k ↗

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