Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78625–78648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K002241 · DZE
Quantum Bioengineering, Ltd.
Dental · 423d
Cleared Sep 20, 2001
GSA GENITO SENSORY ANALYZER
K010981 · LLN
Medoc Ltd. Advanced Medical Systems
Neurology · 171d
Cleared Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K011223 · DZE
Paxmed International
Dental · 153d
Cleared Sep 20, 2001
INSIGHT MILLENNIUM PLUS
K011964 · HCC
Fasstech
Neurology · 87d
Cleared Sep 20, 2001
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
K011988 · OCL
Cardiofocus, Inc.
Cardiovascular · 86d
Cleared Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC
Agfa Corp.
Radiology · 85d
Cleared Sep 20, 2001
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
K012033 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 83d
Cleared Sep 20, 2001
KINETIC CANNULA
K012042 · QPB
Reliance Medical Corp.
General & Plastic Surgery · 83d
Cleared Sep 20, 2001
OPTIBOND SOLO PLUS ACTIVATOR
K012082 · KLE
Sybron Dental Specialties, Inc.
Dental · 79d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 20, 2001
PATTON ENDO-BAG
K012150 · GCJ
Patton Medical Corp.
General & Plastic Surgery · 72d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018 · MID
Corgenix, Inc.
Immunology · 13d
Cleared Sep 20, 2001
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · DZE
Quantum Bioengineering, Ltd.
Dental · 891d
Cleared Sep 19, 2001
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K003620 · DZE
Nsi
Dental · 301d
Cleared Sep 19, 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · FMF
Orthovita, Inc.
General Hospital · 162d
Cleared Sep 19, 2001
NEUROSOFT'S SOURCE
K011241 · OLX
Neurosoft, Inc.
Neurology · 149d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · LZN
Kensey Nash Corp.
Orthopedic · 90d
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · HSX
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Sep 19, 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · FRN
B.Braun Medical, Inc.
General Hospital · 86d
Cleared Sep 19, 2001
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K011996 · HIL
Procter & Gamble Co.
Obstetrics & Gynecology · 84d
Cleared Sep 19, 2001
RHS HELMET
K012007 · MVA
Restorative Health Svs, Inc.
Neurology · 84d
Cleared Sep 19, 2001
3I CALCIUM SULFATE BONE CEMENT
K012047 · LYC
Implant Innovations, Inc.
Dental · 82d
Cleared Sep 19, 2001
GEODESIC EEG SYSTEM, MODEL 200
K012079 · GWQ
Electrical Geodesics, Incorporated
Neurology · 78d