FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76921–76944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · JWH
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 16, 2001
TWINTRODE ELC 134 ELECTRODE
K012785 · LNS
Healthtronics Surgical Services, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 16, 2001
CYNOSURE PHOTOGENICA ER
K012790 · GEX
Cynosure, Inc.
General & Plastic Surgery · 88d
Cleared Nov 16, 2001
INTEX SCREW
K012798 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared Nov 16, 2001
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
K012819 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 85d
Cleared Nov 16, 2001
INTUITIVE SURGICAL BIPOLAR FORCEPS
K012833 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Nov 16, 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
K012856 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
K012880 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200...
K012896 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K013082 · LIH
Mednet Services, Inc.
Neurology · 63d
Cleared Nov 16, 2001
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · CEO
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA...
K013101 · JFJ
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
K013119 · JJX
Maine Standards Co.
Chemistry · 59d
Cleared Nov 16, 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · NBW
Polymer Technology Systems, Inc.
Chemistry · 52d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · DFC
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 16, 2001
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
K013274 · NEW
Cp Medical
General & Plastic Surgery · 46d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013440 · MNI
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
ISOLA POLYAXIAL WASHER
K013441 · KWP
Depuyacromed
Orthopedic · 30d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013444 · MNH
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Nov 16, 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Nov 16, 2001
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
K013499 · GEX
Diomed, Inc.
General & Plastic Surgery · 25d