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

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176,076 results
166489–166512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1980
MICRO-BOND HI-LIFE PROCELAIN & VIVERE
K802235 · EIH
Howmedica Corp.
Dental · 11d
Cleared Sep 26, 1980
3M HI-STRENGTH MED. TAPE #1534
K802242 · KGX
3M Company
General & Plastic Surgery · 10d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPES
K802247 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 10d
Cleared Sep 26, 1980
DISARP ORIGINAL
K802248 · GAO
Unoplast A/S
General & Plastic Surgery · 10d
Cleared Sep 26, 1980
AIR COMPRESSOR ADAPTOR KIT
K802253 · BTI
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 10d
Cleared Sep 26, 1980
AMES TDA PHENOBARBITAL TEST
K802255 · LET
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Sep 26, 1980
STOPCOCK 2-WAY, 3-WAY & 4-WAY
K802258 · FMG
Stanco Medical, Inc.
General Hospital · 10d
Cleared Sep 26, 1980
COMPUTER ECG TERMINAL
K802272 · DSI
Compumed, Inc.
Cardiovascular · 9d
Cleared Sep 25, 1980
PROPHYLACTIC W/SPERMICIDAL LUBRICANT
K802354
Schmid Laboratories, Inc.
Obstetrics & Gynecology
Cleared Sep 19, 1980
START IT WITH & WITHOUT I.V. CATH. UNIT
K801537 · FOZ
Pioneer Viggo, Inc.
General Hospital · 78d
Cleared Sep 18, 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793 · DXY
Telectronics, Inc.
Cardiovascular · 162d
Cleared Sep 17, 1980
LEUKOCYTE VOL. ANALYSIS APPARATUS
K802208 · GKL
Coulter Electronics, Inc.
Hematology · 6d
Cleared Sep 16, 1980
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
K801098 · GOL
Flow Laboratories, Inc.
Microbiology · 130d
Cleared Sep 16, 1980
DATASON RTL
K801454 · IYO
General Electric Co.
Radiology · 84d
Cleared Sep 16, 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508 · DXY
Siemens Elema AB
Cardiovascular · 78d
Cleared Sep 16, 1980
BLOOD GLUCOSE TESTER
K801536 · JJQ
Broomer Research Corp.
Chemistry · 75d
Cleared Sep 16, 1980
SUN VALLEY TANS
K801543 · LEJ
Sun Valley Tans, Inc.
Radiology · 71d
Cleared Sep 16, 1980
CAULK PRISMA-LITE
K801588 · EBZ
Dentsply Intl.
Dental · 67d
Cleared Sep 16, 1980
CYNERGY MODEL 184
K801596 · DTE
Cynergy
Cardiovascular · 64d
Cleared Sep 16, 1980
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
K801661 · DDB
J.T. Baker Chemical Co.
Immunology · 57d
Cleared Sep 16, 1980
J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.
K801662 · DEP
J.T. Baker Chemical Co.
Immunology · 57d
Cleared Sep 16, 1980
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
K801669 · DEM
J.T. Baker Chemical Co.
Immunology · 56d
Cleared Sep 16, 1980
SUN ROOM TANNING BOOTH
K801674 · LEJ
Sun Tan Enterprises, Inc.
Radiology · 56d
Cleared Sep 16, 1980
SONATRON ULTRASONIC DENTAL SCANNER
K801689 · ELC
Simplified Systems, Inc.
Dental · 55d