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Week of Mar 31, 2025

39

Apr 3, 2025device 510k496d 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 510k496d 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 510k496d 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 510k496d 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 510k496d 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 510k496d 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 510k496d 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 510k496d 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 510k496d agoMasimo Corporation — Masimo W1 (510k cleared)MASIMO CORP

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

full page →fda device 510k ↗

Apr 4, 2025approval495d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

full page →tedizolid phosphate →fda approvals ↗

Apr 4, 2025approval495d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

full page →tedizolid phosphate →fda approvals ↗

Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

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

full page →AMBRISENTAN →fda approvals ↗

Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

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

full page →AMBRISENTAN →fda approvals ↗

Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

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

full page →fda approvals ↗

Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

Apr 4, 2025device 510k495d 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 510k495d 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 510k495d 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 510k495d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d 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 510k495d 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 510k495d 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 510k495d 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 510k495d 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 510k495d 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 ↗

Apr 4, 2025device 510k495d agoApex BioTechnology Corp. — UASure II Blood Uric Acid Monitoring System (510k cleared)PDS Biotechnology Corp

Product code: PTC. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoDraegerwerk AG & CO Kgaa — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoRaySearch Laboratories AB (PUBL) — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoWhoop., Inc. — WHOOP ECG (electrocardiogram) Feature (1.0) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoSpectrum Spine, Inc. — Spectrum Spine Lumbar Cage System (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoFoqus Technologies, Inc. — DeepFoqus (DeepFoqus-Accelerate) (510k cleared)FOXO TECHNOLOGIES INC.

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoDegen Medical — DeGen Medical Patient Specific Implant (PSI) System (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (510k cleared)Fresenius Medical Care AG

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d ago3Shape TRIOS A/S — TRIOS Ready Tip (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoOculogica, Inc. — EyeBOX EBX-4.1 (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoQfr Solutions BV — QFR (3.0) (510k cleared)

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

full page →fda device 510k ↗

Apr 4, 2025device 510k495d agoSeigla Medical, Inc. — LiquID .051 LP Guide Catheter Extension (510k cleared)

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

full page →fda device 510k ↗

Week of Apr 7, 2025

11

Apr 7, 2025approval492d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Apr 7, 2025approval

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