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Week of Mar 24, 2025

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Mar 26, 2025recall512d agoGolden State Medical Supply Inc. recall (Cls II)Apotex Corp

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 — Reason: Failed Dissolution Specifications — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall512d agoRising Pharma Holding, Inc. recall (Cls II)CHINA PHARMA HOLDINGS, INC.

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025device 510k512d agoSb-Kawasumi Laboratories, Inc. — SB Knife Jr2 (MD-47702 and MD-47702L) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoArthrex, Inc. — Arthrex Humeral Plating System and Cerclage Button (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoArrow International, LLC — AC3 Range Intra-Aortic Balloon Pump (510k cleared)Arrow International LLC

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoBridge TO Life — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoNingbo Youhuan Automation Technology Co., Ltd. — Power Wheelchair (YH-E6011,YH-E6013A) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoMde Orvosbiológiai Kutató, Fejleszto, — NM-01/CPT neurometer (NM-01/CPT) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoEarlitec Diagnostics — EarliPoint System (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoAZmed — Rayvolve LN (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoKent Imaging, Inc. — SnapshotGLO (KB100) (510k cleared)

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

full page →fda device 510k ↗

Mar 26, 2025device 510k512d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025approval511d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval511d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval511d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval511d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Mar 27, 2025device 510k511d agoZmi Electronics , Ltd. — Levina Pelvic Floor Muscle Stimulator (RS-48) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoBiocorp Production — MallyaD injection pen adapter (MallyaD) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoArtrya Limited — Salix Central (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoEdwards Lifesciences — Edwards eSheath Optima introducer set (510k cleared)Edwards Lifesciences Corp

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoAccess Vascular, Inc. — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoAsahi Intecc Co., Ltd. — Crossloop (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoThreadstone, LLC — HyperSuture White/Green Extension Line (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoRestor3D, Inc. — iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoScivita Medical Technology Co., Ltd. — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoFotona D.O.O. — StarFormer (M008-3T) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoMedtronic, Inc. — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (510k cleared)Medtronic plc

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoHC Biologics, LLC — HC Biologics Osteopoint Spinal Fixation System (510k cleared)Hema Biologics LLC

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoV5med, Inc. — V5med Lung AI (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2025device 510k511d agoHeadsafe Mfg Pty, Ltd. — Nurochek-Pro System (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025approval510d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗

Mar 28, 2025approval510d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗

Mar 28, 2025approval510d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Mar 28, 2025approval510d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Mar 28, 2025approval510d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: BRAEBURN. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

Mar 28, 2025approval510d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Mar 28, 2025approval510d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 28, 2025approval510d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 28, 2025device 510k510d agoMedphoton GmbH — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoSiemens Healthcare Diagnostic Products GmbH — INNOVANCE Antithrombin (510k cleared)

Product code: JBQ. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoWuxi Jiajian Medical Instrument Co., Ltd. — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoBeckman Coulter, Inc. — Access Toxo IgG (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoConvatec — Flexi-Seal AIR (with ENFit Connector) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoMakani Science, Inc. — Makani Science Respiration Monitoring System (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoTuring Medical Technologies, Inc. — Bullsai Confirm (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoSmith & Nephew, Inc. — CATALYSTEM Femoral Stems (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗

Mar 28, 2025device 510k510d agoSynthes GmbH — Synthes Graphic Case & Tray System (510k cleared)

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

full page →fda device 510k ↗

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