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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78769–78792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL...
K010689 · GEX
Biolitec, Inc.
General & Plastic Surgery · 71d
Cleared May 18, 2001
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
K010690 · DZL
Synthes (Usa)
Dental · 71d
Cleared May 18, 2001
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
K010710 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 70d
Cleared May 18, 2001
FISTULOK FISTULA NEEDLE PROTECTION
K010958 · FMI
Diasol, Inc.
General Hospital · 49d
Cleared May 18, 2001
TINA-QUANT ALPHA-1 ANTITRYPSIN
K010978 · DEM
Rochdiag
Immunology · 66d
Cleared May 18, 2001
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
K011169 · JJY
International Enzymes, Inc.
Chemistry · 31d
Cleared May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
K011188 · IYN
GE Medical Systems
Radiology · 30d
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared May 18, 2001
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
K011233 · CGA
Apex BioTechnology Corp.
Chemistry · 25d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Hardy Diagnostics
Microbiology · 11d
Cleared May 17, 2001
STEREOTACTIC FRAME BASED SYSTEM
K003486 · HAW
Stryker Instruments
Neurology · 185d
Cleared May 17, 2001
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K010101 · JWH
Kinamed, Inc.
Orthopedic · 126d
Cleared May 17, 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 119d
Cleared May 17, 2001
RADCALC, MODEL V.4.0
K010464 · IYE
Lifeline Software, Inc.
Radiology · 90d
Cleared May 17, 2001
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K010551 · NDF
Ebi, L.P.
Orthopedic · 80d
Cleared May 17, 2001
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
K010620 · GCJ
Onux Medical, Inc.
General & Plastic Surgery · 77d
Cleared May 17, 2001
CLASSIC CEM
K011064 · EMA
S & C Polymer GmbH
Dental · 41d
Cleared May 17, 2001
XSE
K011167 · KLE
3M Company
Dental · 31d
Cleared May 17, 2001
SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE,...
K011198 · LZA
Maxxim Medical, Inc.
General Hospital · 28d
Cleared May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · LDJ
Syva Co., Dade Behring, Inc.
Toxicology · 17d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · DIP
Syva Co.
Toxicology · 15d
Cleared May 16, 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · DZE
Lifecore Biomedical, Inc.
Dental · 315d
Cleared May 16, 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084 · DQX
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · DQO
Concentric Medical, Inc.
Cardiovascular · 225d