PMA approvals
Premarket approvals for Class III devices and their supplements: trade name, applicant and decision. 57,238 records; openFDA updated it 2026-10-05. About this dataset
Newest records
- APPR28,521
- OK3027,889
- APWD402
- APRL354
- APCB11
- APCV6
- Guardant360 CDxFDA page
Guardant Health, Inc. · Next generation sequencing oncology panel, somatic or germline variant detection system · Pathology
- Novocure GmbHs Optune GioFDA page
Novocure, GmbH · Stimulator, low electric field, tumor treatment · Neurology
- Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar FormFDA page
Integra LifeSciences Corporation · Agent, absorbable hemostatic, collagen based · General, Plastic Surgery
- SELUTION SLR 014 PTCA Drug-Eluting BalloonFDA page
MedAlliance, LLC · Drug-eluting percutaneous transluminal coronary angioplasty catheter · Cardiovascular
- Quattrode®; Octrode; Penta; Lamitrode; Tripole; TriCentrus Lead ExtensionsFDA page
ABBOTT MEDICAL · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
- SURGIFOAM® Absorbable Gelatin SpongeFDA page
Ferrosan Meidcal Devices A/S · Agent, absorbable hemostatic, collagen based · General, Plastic Surgery
- FoundationOne Liquid CDx (F1LCDx)FDA page
Foundation Medicine, Inc. · Next generation sequencing oncology panel, somatic or germline variant detection system · Pathology
- CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental SurgeryFDA page
Integra Lifesciences Corp. · MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID · Dental
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar FoFDA page
Integra LifeSciences Corporation · Agent, absorbable hemostatic, collagen based · General, Plastic Surgery
- Restylane® ContourFDA page
Q-Med AB · Implant, dermal, for aesthetic use · General, Plastic Surgery
- INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal RegeFDA page
Integra Lifesciences Corp. · Dressing, wound and burn, interactive · General, Plastic Surgery
- Epic Plus, Epic Plus Supra, Epic Max, Epic Elite, Epic Supra G3 Tissue Heart ValvesFDA page
ABBOTT MEDICAL · heart-valve, non-allograft tissue · Cardiovascular
- CLARION MULTI-STRATEGY COCHLEAR IMPLANTFDA page
Advanced Bionics · Implant, cochlear · Ear, Nose, Throat
- SCULPTRA® (injectable poly-L Lactic acid)FDA page
Q-Med AB · Implant, dermal, for aesthetic use · General, Plastic Surgery
- PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky SR-T, Amvia EdgFDA page
Biotronik, Inc. · implantable pacemaker Pulse-generator · Cardiovascular
- Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac BranchFDA page
Cook, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Cardiovascular
- Synergy DiscFDA page
Synergy Spine Solutions, Inc. · Prosthesis, intervertebral disc · Orthopedic
- PSW 2601.U, NEO 2601.UFDA page
Biotronik, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) · Cardiovascular
- PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, RFDA page
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
- Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, RivaFDA page
Biotronik, Inc. · Implantable cardioverter defibrillator (non-CRT) · Cardiovascular
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.