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
161833–161856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1982
SUBCLAVIAN INSERTION KIT
K820171 · FRG
Clinipad Corp.
General Hospital · 40d
Cleared Mar 02, 1982
SYBRON/KERR COMMAND
K820182 · EBF
Sybron Corp.
Dental · 39d
Cleared Mar 02, 1982
ADD'L TERMINAL SUPPORT FOR STAR BASIC
K820244 · IYX
General Electric Co.
Radiology · 32d
Cleared Mar 02, 1982
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · DWS
Howmedica Corp.
Cardiovascular · 29d
Cleared Mar 02, 1982
EXTRACTOR III
K820292
The Anspach Effort, Inc.
General & Plastic Surgery · 27d
Cleared Mar 02, 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
K820304 · FJI
Gambro, Inc.
Gastroenterology & Urology · 26d
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