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
165889–165912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1980
MRM-2 OXYGEN CONSUMPTION MONITOR
K801852 · BZL
Waters Assoc., Inc.
Anesthesiology · 16d
Cleared Aug 20, 1980
BARRIER TOWEL DRAPE
K801863 · KKX
Surgikos, Inc.
General Hospital · 15d
Cleared Aug 20, 1980
BARRIER APERTURED DRAPE
K801864 · KKX
Surgikos, Inc.
General Hospital · 15d
Cleared Aug 20, 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865 · DYG
Cordis Corp.
Cardiovascular · 15d
Cleared Aug 20, 1980
DISPOSABLE MEDICATION NEBULIZER
K801867 · LCQ
Hospitax
Toxicology · 15d
Cleared Aug 20, 1980
BURR, DENTAL
K801886 · EJL
Aesculap Instruments Corp.
Dental · 23d
Cleared Aug 20, 1980
DRILL, DENTAL
K801887 · DZA
Aesculap Instruments Corp.
Dental · 23d
Cleared Aug 20, 1980
HANDPIECE, DENTAL
K801888 · DZA
Aesculap Instruments Corp.
Dental · 23d
Cleared Aug 20, 1980
MUELLER HINTON AGAR
K801901 · JTZ
Radiation Technology, Inc.
Microbiology · 12d
Cleared Aug 20, 1980
ENZYME-ASE I TUBES
K801915 · JTO
Microchemical Specialities, Co.
Microbiology · 9d
Cleared Aug 20, 1980
ORNITH-ASE TUBES
K801916 · JTO
Microchemical Specialities, Co.
Microbiology · 9d
Cleared Aug 20, 1980
LAB-TEK FTA-ABS KIT
K801928 · JWL
Miles Laboratories, Inc.
Microbiology · 8d
Cleared Aug 14, 1980
ELECTRONIC PACEMAKER WAVEFORM ANALYZER
K800696 · KRE
Instromedix, Inc.
Cardiovascular · 139d
Cleared Aug 14, 1980
MODIFIED BLOOD CELL COUNTING & LYSING
K801357 · GIF
Coulter Electronics, Inc.
Hematology · 66d
Cleared Aug 14, 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450 · DXY
Intermedics, Inc.
Cardiovascular · 55d
Cleared Aug 14, 1980
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM
K801576 · GZJ
Inter Med Industries, Inc.
Neurology · 36d
Cleared Aug 14, 1980
ADEL MEDICAL BIRTHING BED, MOD. LD-400
K801622 · KNC
Adel Medical , Ltd.
Obstetrics & Gynecology · 30d
Cleared Aug 14, 1980
RIONET HEARING AID AND/OR RION #HB-70
K801692 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 14, 1980
MMI/GAELTEC CATHETER INTRAUTERINE
K801758 · KXO
Medical Measurements, Inc.
Obstetrics & Gynecology · 17d
Cleared Aug 14, 1980
CATHETER SUCTION TRACHEOBRONCHIAL
K801814 · BSY
Concord Laboratories, Inc.
Anesthesiology · 15d
Cleared Aug 14, 1980
CIRCUITS, BREATHING W/CONNECTORS, ADAPT
K801875 · CAF
Airlife, Inc.
Anesthesiology · 9d
Cleared Aug 14, 1980
MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS
K801880 · BYR
Medical Measurements, Inc.
Anesthesiology · 7d
Cleared Aug 13, 1980
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · FOZ
G.D. Searle and Co.
General Hospital · 58d
Cleared Aug 13, 1980
CHEMDI
K801428 · JOJ
American Sterilizer Co.
General Hospital · 57d