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
165649–165672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 16, 1980
TOXO BIO-BEAD TITRATION KIT
K801720 · GLZ
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
HSV BIO-BEAD TITRATION KIT
K801721 · GQN
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
CMV BIO-BEAD TITRATION KIT
K801722 · GQH
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
FENZL RETICLE
K801733 · HOI
Robert E. Fenzl, M.D.
Ophthalmic · 53d
Cleared Sep 16, 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · CGI
Bd Becton Dickinson Vacutainer...
Chemistry · 53d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749 · CEK
Beckman Instruments, Inc.
Chemistry · 50d