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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,396 phase readout · 2,291 8k filing · 2,000 device pma

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soonest latest type sponsor alpha

type: device pma×clear all

type

approval18,987
device 510k5,000
grant4,728
phase readout4,396
8k filing2,291
device pma2,000
device recall2,000

recall1,126

device adverse event1,000

earnings289

therapy area

no tagged catalysts yet

Week of Jun 23, 2025

›Jun 27, 2025device pma387d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators (PMA supplement)

Supplement type: Real-Time Process. Product code: QMG. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

›Jun 27, 2025device pma387d agoAgilent Technologies, Inc. — PD-L1 IHC 28-8 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

›Jun 27, 2025device pma387d agoTempus Labs, Inc. — xT CDx (PMA supplement)Tempus AI, Inc.

Supplement type: Real-Time Process. Product code: PQP. Advisory committee: PA. Decision: APPR

full page →fda device pma ↗

Week of Jun 30, 2025

›Jun 30, 2025device pma384d agoPhysio-Control, Inc. — LIFEPAK FLEX Lithium-ion Battery (PMA supplement)

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

full page →fda device pma ↗

›Jun 30, 2025device pma

Week of Jul 7, 2025

›Jul 7, 2025device pma377d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

›Jul 7, 2025device pma

← prev

page 6 of 40

384d ago

Baxter Healthcare Corp — FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (PMA supplement)Baxter Healthcare Corp

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

full page →fda device pma ↗

›Jun 30, 2025device pma384d agoNevro Corporation — Nevro Corp Senza Spinal Cord Stimulation (SCS) System (PMA supplement)

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

full page →fda device pma ↗

›Jun 30, 2025device pma384d agoTherakos Development Limited — THERAKOS® CELLEX® Photopheresis System Procedural Kit (PMA supplement)

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

full page →fda device pma ↗

›Jul 1, 2025device pma383d agoOrganox Limited — OrganOx metra System (PMA supplement)

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

full page →fda device pma ↗

›Jul 1, 2025device pma383d agoSirtex Medical, Inc. — SIR-Spheres Y-90 resin microspheres (PMA supplement)

Supplement type: Panel Track. Product code: NAW. Advisory committee: RA. Decision: APPR

full page →fda device pma ↗

›Jul 1, 2025device pma383d agoCook Ireland, Ltd. — Zilver Flex(R) 35 Vascular Stent (PMA supplement)

Supplement type: Panel Track. Product code: NIP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

›Jul 1, 2025device pma383d agoTransMedics, Inc. — Organ Care System (OCS) Liver (PMA supplement)TransMedics Group, Inc.

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

full page →fda device pma ↗

›Jul 1, 2025device pma383d agoBoston Scientific Corp — AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

›Jul 1, 2025device pma383d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoMedtronic, Inc. — MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoAbbott Vascular — RX HERCULINK ELITE RENAL STENT SYSTEM (PMA supplement)

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

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›Jul 2, 2025device pma382d agoABBOTT MEDICAL — Proclaim DRG IPG (PMA supplement)

Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30

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›Jul 2, 2025device pma382d agoMedtronic Cardiac Rhythm Disease Management — VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (PMA supplement)

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

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoABBOTT MEDICAL — Infinity DBS IPG (PMA supplement)

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

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›Jul 2, 2025device pma382d agoBecton, Dickinson and Company — BD Onclarity HPV Assay (PMA supplement)BECTON DICKINSON & CO

Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoLife Technologies Corporation — Oncomine Dx Express Test (PMA)

Product code: PQP. Advisory committee: PA. Decision: APPR

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoABBOTT MEDICAL — Aveir VR and DR Delivery Catheters (PMA supplement)

Supplement type: Real-Time Process. Product code: PNJ. Advisory committee: CV. Decision: APPR

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›Jul 2, 2025device pma382d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

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

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›Jul 2, 2025device pma382d agoABBOTT MEDICAL — Proclaim SCS IPG (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoMedtronic, Inc. — MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

›Jul 2, 2025device pma382d agoMedtronic, Inc. — MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (PMA supplement)Medtronic plc

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

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›Jul 2, 2025device pma382d agoMedtronic Cardiac Rhythm Disease Management — CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (PMA supplement)

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

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoCochlear Americas — Nucleus® 22 Cochlear Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoCochlear Americas — Nucleus® Hybrid L24 Cochlear Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: PGQ. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoFarapulse, Inc. — FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C (PMA supplement)

Supplement type: Panel Track. Product code: QZI. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoCochlear Americas — Nucleus® 24 Auditory Brainstem Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MHE. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoDefibtech, LLC — Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MKJ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoCook Ireland, Ltd. — Zilver® PTX® Peripheral Drug-Eluting Stent (PMA supplement)

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

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

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

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoInsightec — Exablate Model 4000 Type-1 System (PMA supplement)

Supplement type: Panel Track. Product code: POH. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoMentor Corp. — MENTOR MemoryGel Enhance Breast Implants (PMA supplement)

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

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoCochlear Americas — Nucleus® 22 Cochlear Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

›Jul 3, 2025device pma381d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

377d ago

Atrium Medical Corp. — iCast Covered Stent System (PMA supplement)Apyx Medical Corp

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

full page →fda device pma ↗

›Jul 8, 2025device pma376d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

›Jul 8, 2025device pma376d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

›Jul 9, 2025device pma375d agoMedtronic, Inc. — Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

›Jul 9, 2025device pma375d agoBausch & Lomb, Inc. — Akreos Posterior Chamber Intraocular Lens (IOL) (PMA supplement)Bausch & Lomb Corp

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

full page →fda device pma ↗

›Jul 9, 2025device pma375d agoMedtronic, Inc. — Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

›Jul 9, 2025device pma375d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD, Cobalt XT MRI ICD (PMA supplement)

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

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›Jul 9, 2025device pma375d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (PMA supplement)

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

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$TMDX69.43-2.72%

$MDT83.20-0.43%

$A131.46-3.41%

$TEM

$MDT83.20-0.43%

$BDX158.17-1.10%

$BSX44.03-1.32%

$MDT83.20-0.43%

$IGC0.2670+0.41%

$APYX

$EW91.33-2.47%

$MDT83.20-0.43%

$EW91.33-2.47%

$MDT83.20-0.43%

$BLCO16.26-3.27%

$MDT83.20-0.43%