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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 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
phase readout4,876
grant4,728
8k filing2,415
device pma2,000
device recall2,000

recall1,126

device adverse event1,000

earnings295

therapy area

no tagged catalysts yet

Week of Feb 23, 2026

›Feb 27, 2026device pma150d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

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

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›Feb 28, 2026device pma149d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

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Week of Mar 2, 2026

›Mar 2, 2026device pma147d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (LVAS) (PMA supplement)

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

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›Mar 2, 2026device pma

← prev

page 36 of 40

147d ago

Alcon Laboratories, Inc. — AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

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›Mar 2, 2026device pma147d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

full page →fda device pma ↗

›Mar 2, 2026device pma147d agoAlcon Research, Ltd. — AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

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

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›Mar 2, 2026device pma147d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

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›Mar 2, 2026device pma147d agoAbbott Vascular, Inc. — Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

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›Mar 2, 2026device pma147d agoAbbott Vascular Devices — StarClose SE Vascular Closure System (PMA supplement)

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

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›Mar 2, 2026device pma147d agoAlcon Laboratories, LLC — Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL (PMA supplement)Alcon Laboratories Inc

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

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›Mar 3, 2026device pma146d agoMedtronic, Inc. — Mosaic Neo Mitral Bioprosthesis (PMA supplement)Medtronic plc

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

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›Mar 3, 2026device pma146d agoPerimeter Medical Imaging Ai, Inc. — Claire OCT System (PMA)

Product code: SHH. Advisory committee: SU. Decision: APPR

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›Mar 3, 2026device pma146d agoMedtronic, Inc. — HexaGen RF Generator (PMA supplement)Medtronic plc

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

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›Mar 3, 2026device pma146d agoValencia Technologies Corporation — eCoin Peripheral Neurostimulator (PMA supplement)

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

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›Mar 4, 2026device pma145d agoLivaNova USA, Inc. — VNS Therapy® System (PMA supplement)

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

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›Mar 4, 2026device pma145d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

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›Mar 4, 2026device pma145d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M (PMA supplement)

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

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›Mar 4, 2026device pma145d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (PMA supplement)

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

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›Mar 4, 2026device pma145d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I (PMA supplement)

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

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›Mar 4, 2026device pma145d agoSTAAR Surgical Company — The EVO/EVO+ Visian Implantable Collamer Lens (ICL) (PMA supplement)STAAR SURGICAL CO

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

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›Mar 4, 2026device pma145d agoLife Technologies Corporation — Oncomine Dx Target Test (PMA supplement)

Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR

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›Mar 4, 2026device pma145d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

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›Mar 4, 2026device pma145d agoCooperVision, Inc. — Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

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›Mar 4, 2026device pma145d agoCooperVision, Inc. — Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

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›Mar 5, 2026device pma144d agoBiotronik, Inc. — Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk (PMA supplement)

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

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›Mar 5, 2026device pma144d agoShockwave Medical, Inc. — Shockwave lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter (PMA supplement)

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

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›Mar 5, 2026device pma144d agoBoston Scientific Corp — ROTAPRO Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

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›Mar 5, 2026device pma144d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

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›Mar 5, 2026device pma144d agoInsightec — Exablate Model 4000 Type 1.0 and 1.1 (Exablate Neuro; Exablate Prime) (PMA supplement)

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

full page →fda device pma ↗

›Mar 5, 2026device pma144d agoBiotronik, Inc. — Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (PMA supplement)

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

full page →fda device pma ↗

›Mar 5, 2026device pma144d agoBiotronik, Inc. — Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 (PMA supplement)

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

full page →fda device pma ↗

›Mar 5, 2026device pma144d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

full page →fda device pma ↗

›Mar 5, 2026device pma144d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

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›Mar 5, 2026device pma144d agoPhysio-Control, Inc. — LIFEPAK 35 monitor/defibrillator (PMA supplement)

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

full page →fda device pma ↗

›Mar 6, 2026device pma143d agoKestra Medical Technologies, Inc. — ASSURE Wearable Cardioverter Defibrillator (WCD) System (PMA supplement)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

full page →fda device pma ↗

›Mar 6, 2026device pma143d agoEuclid Vision Corporation — Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NUU. Advisory committee: OP. Decision: APPR

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›Mar 6, 2026device pma143d agoMedtronic, Inc. — HV Splitter/ Adaptor kit (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

›Mar 6, 2026device pma143d agoBiomet Manufacturing Corp — Oxford Cementless Partial Knee System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

›Mar 6, 2026device pma143d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev (PMA supplement)

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

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›Mar 6, 2026device pma143d agoABBOTT MEDICAL — TriClip G4 System (PMA supplement)

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

full page →fda device pma ↗

›Mar 6, 2026device pma143d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

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

full page →fda device pma ↗

›Mar 6, 2026device pma143d agoMedtronic, Inc. — IN.PACT 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)Medtronic plc

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

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›Mar 6, 2026device pma143d agoBoston Scientific — ENDOTAK RELIANCE / RELIANCE 4-FRONT pace/sense defibrillation leads (PMA supplement)BOSTON SCIENTIFIC CORP

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

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›Mar 6, 2026device pma143d agoMedtronic, Inc. — Harmony TPV System (PMA supplement)Medtronic plc

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

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›Mar 6, 2026device pma143d agoTMJ Concepts — TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (PMA supplement)

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

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›Mar 6, 2026device pma143d agoMedtronic, Inc. — Aurora EV ICD; Epsila EV Extravascular Lead (PMA supplement)Medtronic plc

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

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›Mar 6, 2026device pma143d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® FORTEGRA Venous Stent (PMA supplement)

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

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›Mar 6, 2026device pma143d agoABBOTT MEDICAL — MitraClip NTR/XTR Clip Delivery System; MitraClip G4 System (PMA supplement)

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

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›Mar 6, 2026device pma143d agoBioventus, LLC — SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A (PMA supplement)Bioventus Inc.

Supplement type: 30-Day Notice. Product code: LOF. Advisory committee: OR. Decision: OK30

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›Mar 6, 2026device pma143d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

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$MDT83.21+1.46%

$STAA23.38-3.35%

$MDT83.21+1.46%

$BSX44.25+1.54%

$KMTS20.35+8.13%

$MDT83.21+1.46%

$BSX44.25+1.54%

$MDT83.21+1.46%

$BVS8.6700+1.40%