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Week of Jun 16, 2025

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Jun 16, 2025device pma422d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Jun 16, 2025device pma422d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Jun 16, 2025device pma422d agoMerz North America, Inc. — COAPTITE® (PMA supplement)

Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jun 16, 2025device 510k422d agoExpanding Innovations, Inc. — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoSiemens Healthcare GmbH — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoBeckman Coulter, Inc. — Access hsTnI (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoGuangdong Ecan Medical Co., Ltd. — Silicone Urethral Catheter (Silicone Urethral Catheter) (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoNavier Medical — Mosaic (V1.0.1) (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoSiemens Shenzhen Magnetic Resonance , Ltd. — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoGeomedi Co,., Ltd. — Geo Abutment (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoMethinks Software, S.L — Methinks NCCT Stroke (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoEvoEndo, Inc. — EvoEndo Single-Use Endoscopy System (510k cleared)

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

full page →fda device 510k ↗

Jun 16, 2025device 510k422d agoBecton, Dickinson and Company — BD Veritor System for SARS-CoV-2 (510k cleared)BECTON DICKINSON & CO

Product code: QVF. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗

Jun 17, 2025approval421d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Jun 17, 2025approval421d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jun 17, 2025approval421d agoMEFENAMIC ACID — FDA approvalMEFENAMIC ACID

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

full page →MEFENAMIC ACID →fda approvals ↗

Jun 17, 2025approval421d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗

Jun 17, 2025device pma421d agoMedtronic, Inc. — Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Microny family of Pacemakers (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWO. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base, 24970A (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Aveir Leadless System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: PNJ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗

Jun 17, 2025device pma421d agoAtriCure, Inc. — Synergy Ablation System (PMA supplement)AtriCure, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoMedtronic, Inc. — Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NKE. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Assurity, Assurity+, Endurity, Accent family of Pacemakers (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation System (PMA)

Product code: EZW. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWS. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoABBOTT MEDICAL — Assurity MRI, Endurity MRI family of Pacemakers (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoAtriCure, Inc. — EPi-Sense Guided Coagulation System (PMA supplement)AtriCure, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Jun 17, 2025device pma421d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) (PMA supplement)

Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗

Jun 17, 2025device 510k421d agoFziomed, Inc. — Oxiplex® (510k cleared)

Product code: QVL. Advisory committee: Orthopedic. Type: Direct

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoNano-Ditech Corporation — Nano-Check Influenza+COVID-19 Dual Test (510k cleared)

Product code: SCA. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoKl-Kepong Rubber Products Sdn. Bhd. — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoVitalSigns Technology Co., Ltd. — VitalSigns 1-Lead Holter (VSH101) (510k cleared)Viomi Technology Co., Ltd

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoAnika Therapeutics, Inc. — Integrity Implant (510k cleared)Anika Therapeutics, Inc.

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoBridge TO Life — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (510k cleared)Revalesio Corp

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoBard Peripheral Vascular, Inc. — Dorado PTA Balloon Dilatation Catheter (510k cleared)

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoShanghai United Imaging Healthcare Co., Ltd. — uOmniscan (510k cleared)

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoBrainlab AG — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (510k cleared)

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoTissium SA — COAPTIUM Connect with TISSIUM LIGHT (510k cleared)

Product code: SFD. Advisory committee: Neurology. Type: Direct

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (510k cleared)

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

full page →fda device 510k ↗

Jun 17, 2025device 510k421d agoWuxi Hisky Medical Technologies Co., Ltd. — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (510k cleared)

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

full page →fda device 510k ↗

Jun 18, 2025approval420d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗

Jun 18, 2025approval420d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

Jun 18, 2025approval420d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

Jun 18, 2025approval420d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jun 18, 2025approval420d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗

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