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calendar

19 catalysts · 12 device 510k · 4 device pma · 3 approval

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  • device 510k12
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therapy area

no tagged catalysts yet

Week of Jun 2, 2025

19
›Jun 3, 2025approval
454d ago
KEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗
›Jun 3, 2025approval454d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗
›Jun 3, 2025approval454d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Jun 3, 2025device pma454d agoBoston Scientific Corp — AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: EZY. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗
›Jun 3, 2025device pma454d agoInspire Medical Systems — Inspire Upper Airway Stimulation (UAS) (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 135 Review Track For 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: APPR

full page →fda device pma ↗
›Jun 3, 2025device pma454d agoInsightec — Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) (PMA supplement)

Supplement type: Real-Time Process. Product code: POH. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗
›Jun 3, 2025device pma454d agoCardiovascular Systems, Inc. — Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (PMA supplement)

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

full page →fda device pma ↗
›Jun 3, 2025device 510k454d agoRz Medizintechnik GmbH — RZ Resectoscope System (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoGlove One, LLC — GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (510k cleared)NutriBand Inc.

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoKardium, Inc. — Globe Introducer (601-01001) (510k cleared)Kardigan Inc

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoCintron Medical Corporation — gi2000 Electrosurgical Generator (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoPhasor Health, LLC — EVAC (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoSpinal Simplicity, LLC — Patriot SI Implant System (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoPentax of America, Inc. — PENTAX Medical Video Processor (EPK-i8020c) (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoBalt USA, LLC — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (510k cleared)Bayer USA LLC

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoClemde SA DE CV — Partial Flex (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoAroa Biosurgery , Ltd. — Endoform Reconstructive Template - PLGA (510k cleared)

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

full page →fda device 510k ↗
›Jun 3, 2025device 510k454d agoSerim Research — DISINTEK™ PA Test Strips (510k cleared)

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

full page →fda device 510k ↗
$NTRB2.9000-11.59%
$INSP42.44+0.38%
$BSX46.84+0.36%