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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
139225–139248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1987
TRANSPECT TRANSCRANIAL DOPPLER
K872292 · IYN
Medasonics, Inc.
Radiology · 59d
Cleared Aug 14, 1987
MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM
K872725 · GWE
Eyetronics, Inc.
Neurology · 37d
Cleared Aug 14, 1987
RATE INFUSER SYSTEM
K872850 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 25d
Cleared Aug 14, 1987
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · NAD
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 14d
Cleared Aug 13, 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · LBS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 135d
Cleared Aug 13, 1987
CRITERION II & IIA OXYGEN CONCENTRATORS
K871603 · CAW
Timeter Instrument Corp.
Anesthesiology · 111d
Cleared Aug 13, 1987
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION
K872049 · CGA
Garid, Inc.
Chemistry · 77d
Cleared Aug 13, 1987
TDXR FLECAINIDE
K872175 · LBZ
Abbott Laboratories
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · CDP
Immunotech Corp.
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192 · KLI
Immunotech Corp.
Chemistry · 66d
Cleared Aug 13, 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
K872197 · CIG
Sigma Diagnostics, Inc.
Chemistry · 66d
Cleared Aug 13, 1987
HR (TM) COLLECTION SYSTEM
K872580 · FMI
Icu Medical, Inc.
General Hospital · 44d
Cleared Aug 13, 1987
EASY ST ANALYZER SYSTEM
K872813 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 13, 1987
BIOTROL AST/TGO MONOREACTIF
K872829 · CIT
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
BIOTROL ALT/TGP MONOREACTIF
K872830 · CKA
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
CALCITONIN RIA KIT
K872880 · JKR
Endocrine Associates, Inc.
Chemistry · 23d
Cleared Aug 13, 1987
CARBON DIOXIDE
K872886 · KMS
Catachem, Inc.
Chemistry · 22d
Cleared Aug 13, 1987
LIGHTPLAST(TM)
K872975 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 14d
Cleared Aug 12, 1987
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · LIT
Cook, Inc.
Cardiovascular · 204d
Cleared Aug 12, 1987
PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K871080 · DQY
Catheter Technology Corp.
Cardiovascular · 147d
Cleared Aug 12, 1987
OLYMPUS ANGIOSCOPY PUMP
K871422 · DQI
Olympus Corp.
General Hospital · 125d
Cleared Aug 12, 1987
THE TELESCAN C.A.R.E. SYSTEM
K871587 · DSH
Telescan Medical Systems
Cardiovascular · 110d
Cleared Aug 12, 1987
OSTO-PURE
K871738 · EXB
Clearchem Corp.
Gastroenterology & Urology · 99d
Cleared Aug 12, 1987
CT9800 QUICK 3D #B7919DA
K871859 · JAK
General Electric Co.
Radiology · 91d