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calendar

12 catalysts · 7 device pma · 4 device 510k · 1 approval

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  • device pma7
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therapy area

no tagged catalysts yet

Week of Jun 9, 2025

12
›Jun 9, 2025approval
448d ago
COLUMVI (GLOFITAMAB-GXBM) — FDA approvalglofitamab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →glofitamab →fda approvals ↗
›Jun 9, 2025device pma448d agoABBOTT MEDICAL — Liberta RC Deep Brain Stimulation Implantable Pulse Generator (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗
›Jun 9, 2025device pma448d agoPhilips Medical Systems — HeartStart FRx Defibrillator (861304) (PMA supplement)

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

full page →fda device pma ↗
›Jun 9, 2025device pma448d agoPhilips Medical Systems, Inc. — HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

full page →fda device pma ↗
›Jun 9, 2025device pma448d agoABBOTT MEDICAL — Eterna Spinal Cord Stimulation Implantable Pulse Generator (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗
›Jun 9, 2025device pma448d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: MG. Decision: OK30

full page →fda device pma ↗
›Jun 9, 2025device pma448d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (PMA supplement)JOHNSON & JOHNSON

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

full page →fda device pma ↗
›Jun 9, 2025device pma448d agoMedtronic Neuromodulation — Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int (PMA supplement)

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

full page →fda device pma ↗
›Jun 9, 2025device 510k448d agoOneness Biotech Co., Ltd. — Bonvadis® (510k cleared)Oneness Biotech Co Ltd

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

full page →fda device 510k ↗
›Jun 9, 2025device 510k448d agoNanjing Bestview Laser S&T Co., Ltd. — CO2 Laser Machine (Lume) (510k cleared)

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

full page →fda device 510k ↗
›Jun 9, 2025device 510k448d agoBiocorp Production — MallyaG Injection Pen Adapter (MallyaG) (510k cleared)

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

full page →fda device 510k ↗
›Jun 9, 2025device 510k448d agoShenzhen Sungrow Led Technology Co., Ltd. — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) (510k cleared)

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

full page →fda device 510k ↗
$CAI
$JNJ268.04+0.85%
$MMSI90.49+1.06%