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
147745–147768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1985
EFFNER-EYE CAUTERY WITH BATTERY HANDLE
K844775 · HQO
Mecron Medical Products, Inc.
Ophthalmic · 245d
Cleared Aug 12, 1985
VISION POTASSIUM
K850950 · CEM
Abbott Laboratories
Chemistry · 158d
Cleared Aug 12, 1985
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU
K851323 · DWF
C.R. Bard, Inc.
Cardiovascular · 130d
Cleared Aug 12, 1985
OCULAR PRESSURE REDUCER (MCCANNEL)
K852032 · LCC
Visitec Co.
Ophthalmic · 95d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176 · GHH
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 84d
Cleared Aug 12, 1985
CEPHALINEX ACTIVATED PTT REAGENT
K852195 · GGW
Bio/Data Corp.
Hematology · 84d
Cleared Aug 12, 1985
VECTOR BAR SUSPENSION/TRACTION UNIT
K852398 · ILZ
Powlan Manufacturing Co.
Physical Medicine · 67d
Cleared Aug 12, 1985
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · LZN
Howmedica Corp.
Orthopedic · 63d
Cleared Aug 12, 1985
PLASTINEX
K852484 · GJS
Bio/Data Corp.
Hematology · 62d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
K852519 · JCO
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 56d
Cleared Aug 12, 1985
T-3 RIASSAY
K852537 · CDP
Ria Diagnostics
Chemistry · 59d
Cleared Aug 12, 1985
MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK
K852604 · IRT
Clairol, Inc.
Physical Medicine · 54d
Cleared Aug 12, 1985
HOT PACK
K852610 · IMD
Oriental Medical Supplies, Inc.
Physical Medicine · 54d
Cleared Aug 12, 1985
HUMPHREY IMAGE ANALYZER MODEL 110
K852638 · HKI
Zeiss Humphrey System
Ophthalmic · 53d
Cleared Aug 12, 1985
ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100
K852683 · GEI
American Bentley
General & Plastic Surgery · 48d
Cleared Aug 12, 1985
VISIDEX II REAGENT STRIPS
K852747
Miles Laboratories, Inc.
Chemistry · 46d
Cleared Aug 12, 1985
CEFTAZIDIME 30 MCG SENSITVITY DISCS
K852835 · JTN
Difco Laboratories, Inc.
Microbiology · 41d
Cleared Aug 12, 1985
METALLIC SUNGLASSES
K852902 · HQY
Yours Enterprise Co., Ltd.
Ophthalmic · 34d
Cleared Aug 12, 1985
ENDAB PHENOBARBITAL
K852995 · DLZ
Immunotech Corp.
Toxicology · 28d
Cleared Aug 12, 1985
TRIGLYCERIDES LCK 124
K853041 · CDF
German American Chamber of Commerce,...
Chemistry · 24d
Cleared Aug 12, 1985
CITREX I
K853076 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX II
K853077 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX III
K853078 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
TD TRICYCLIC ANTIDEPRESSANTS
K853113 · LFG
Abbott Laboratories
Toxicology · 19d