FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79273–79296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2001
SCREW-VENT DENTAL IMPLANT SYSTEM
K011028 · DZE
Sulzer Dental, Inc.
Dental · 46d
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · DAP
Kamiya Biomedical Co.
Hematology · 239d
Cleared May 18, 2001
VASO PRESS DVT FOOT GARMENT #VP 520
K003828 · JOW
Britt Corp., Inc.
Cardiovascular · 158d
Cleared May 18, 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021,...
K010162 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 121d
Cleared May 18, 2001
VENA TECH VENA CAVA FILTER
K010485 · DTK
Bbraun
Cardiovascular · 87d
Cleared May 18, 2001
ADVANTA SST GRAFT (>_6MM)
K010516 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
ADVANTA SST GRAFT (<6MM)
K010517 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · FMQ
Skil-Care Corp.
General Hospital · 74d
Cleared May 18, 2001
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
K010672 · GAM
Gramsmed, LLC
General & Plastic Surgery · 73d
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