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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
160993–161016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1982
SPECIAL WHITE
K820318 · EJT
J. Aderer, Inc.
Dental · 25d
Cleared Mar 02, 1982
NICKEL-BASED DENTAL CASTING ALLOY
K820328 · EJH
Dentsply Intl.
Dental · 22d
Cleared Mar 02, 1982
IMPACT, MODEL 303
K820337 · GCX
Impact Instrumentation, Inc.
General Hospital · 22d
Cleared Mar 02, 1982
IMPACT, MODELS 306/307
K820338 · BTA
Impact Instrumentation, Inc.
General & Plastic Surgery · 22d
Cleared Mar 02, 1982
CAST CUTTER/CAST SAW/INSTRUMENT
K820351 · LGH
Black & Decker(Tm)
Orthopedic · 22d
Cleared Mar 02, 1982
REUTER BOBBIN VENTILA. TUBE-TITANIUM
K820362 · ETD
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 21d
Cleared Mar 02, 1982
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
K820397 · LER
American Diagnostic Corp.
Chemistry · 19d
Cleared Mar 02, 1982
DAHLBERG HEARING AID MODEL AL
K820398 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 19d
Cleared Mar 02, 1982
GROUND AID CAPHESIVE
K820405 · KNS
Promedicon, Inc.
Gastroenterology & Urology · 18d
Cleared Mar 02, 1982
TMO INTEGRATED CIRCUIT SYSTEM
K820406 · KRI
Travenol Laboratories, S.A.
Cardiovascular · 18d
Cleared Mar 02, 1982
CLASS OF PRECIOUS METAL CASTING ALLOYS
K820407 · EJS
Howmedica Corp.
Dental · 18d
Cleared Mar 02, 1982
CLASS OF CASTING ALLOYS TYPE IV OR ALT
K820408 · EJS
Howmedica Corp.
Dental · 18d
Cleared Mar 02, 1982
ELECTRONIC CLINICAL THERMOMETER TEMP PR
K820409 · FLL
Y
General Hospital · 18d
Cleared Mar 02, 1982
OTOMET MODEL M-9 HEARING INSTRUMENT
K820425 · ESD
Otomet Corp.
Ear, Nose, Throat · 14d
Cleared Mar 02, 1982
ADDITIONAL TERMINAL SUPPORT FOR STAR TM BASIC SYSTEM
K827104
General Electric Co.
Radiology · 32d
Cleared Mar 01, 1982
VANCE-JACOBELLIS MICROHEMATURIA CATHETER
K812995 · KOD
Vance Products, Inc.
Gastroenterology & Urology · 126d
Cleared Mar 01, 1982
MAVIS C
K813002 · DXK
Philips Medical Systems (Cleveland),...
Radiology · 126d
Cleared Mar 01, 1982
BIOMICROSCOPY CONTACT LENS
K813313 · HJO
Design Research Assoc., Inc.
Ophthalmic · 97d
Cleared Mar 01, 1982
CALIPER-OPTHALMIC
K813315 · HOE
Design Research Assoc., Inc.
Ophthalmic · 97d
Cleared Mar 01, 1982
GROSSE AND KEMPF LOCKING NAIL SYS.
K813371 · HSB
Howmedica Corp.
Orthopedic · 91d
Cleared Mar 01, 1982
SSD-203 ULTRASONIC SCANNER
K813398 · IYO
U. S. A. Imaging Corp.
Radiology · 87d
Cleared Mar 01, 1982
MADAYAG TYPE NEEDLE
K813462 · KNW
Ocean Medical Products, Ltd.
Gastroenterology & Urology · 80d
Cleared Mar 01, 1982
VITAL METRICS URINE MONITORING SYSTEM
K813641 · FFG
Vital Metrics, Inc.
Gastroenterology & Urology · 61d
Cleared Mar 01, 1982
TITANIUM IMPLANT DEVICES
K820013 · DZE
Bofors Nobelpharma, Inc.
Dental · 55d