FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80953–80976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2000
35/CD CINECONVERTER
K001841 · LMA
Tagarno A/S
Radiology · 149d
Cleared Nov 15, 2000
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575 · LWJ
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Nov 15, 2000
LITWIN CRUICATE ANCHOR
K002600 · MBI
Instrument Makar, Inc.
Orthopedic · 86d
Cleared Nov 15, 2000
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
K002843 · EMA
Sultan Chemists, Inc.
Dental · 64d
Cleared Nov 15, 2000
SOLOBOND PLUS
K003153 · KLE
Voco GmbH
Dental · 36d
Cleared Nov 14, 2000
VBMAX
K000654 · CAH
A-M Systems, Inc.
General Hospital · 260d
Cleared Nov 14, 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530 · DXN
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 14, 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
K003308 · FLL
Microlife Corp.
General Hospital · 22d
Cleared Nov 13, 2000
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
K001177 · LYR
Enteric Products, Inc.
Microbiology · 216d
Cleared Nov 13, 2000
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
K001440 · GAT
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 189d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · LFR
Abbott Laboratories
Chemistry · 137d
Cleared Nov 13, 2000
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023 · LYR
Medmira Laboratories, Inc.
Microbiology · 133d
Cleared Nov 13, 2000
AMT SPINAL SYSTEM
K002059 · KWP
Micron Precision Engineering, Inc.
Orthopedic · 130d
Cleared Nov 13, 2000
ROVERS SPATULA
K002520 · HHT
Rovers Medical Devices B.V.
Obstetrics & Gynecology · 90d
Cleared Nov 13, 2000
SPARTAN MTS
K002521 · ELC
Spartan Marketing Group
Dental · 90d
Cleared Nov 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · KRO
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 13, 2000
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · GEH
Endocare, Inc.
General & Plastic Surgery · 83d
Cleared Nov 13, 2000
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
K002677 · BXM
Nuvasive, Inc.
Anesthesiology · 77d
Cleared Nov 13, 2000
TISSUELINK MONOPOLAR FLOATING BALL'
K002680 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 77d
Cleared Nov 13, 2000
ALLON 2001 MODIFIED
K003349 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 18d
Cleared Nov 09, 2000
SAMSUNG 10DR IMPLANT SYSTEM
K002062 · EHD
Samsung Sds Co., Ltd.
Radiology · 126d
Cleared Nov 09, 2000
100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS
K002357 · IYO
Pie Medical
Radiology · 99d
Cleared Nov 09, 2000
REPLACE TPS COATED IMPLANTS
K002475 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Nov 09, 2000
LUMBOPERITONEAL SHUNT SYSTEM
K002476 · JXG
Phoenix Biomedical Corp.
Neurology · 90d