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
87985–88008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1998
MODEL 340GE-21C QUADRATURE BRAIN COIL
K982978 · MOS
Medical Advances, Inc.
Radiology · 90d
Cleared Nov 23, 1998
OSTEO 5.0MM CANNULATED SCREW SYSTEM
K983006 · HWC
Stryker Osteonics
Orthopedic · 87d
Cleared Nov 23, 1998
CUSTOM FLANGED ACETABULAR COMPONENT
K983035 · LPH
Biomet, Inc.
Orthopedic · 84d
Cleared Nov 23, 1998
BPOS-IVAD STABILIZER
K983480 · LJT
Bpos, Inc.
General Hospital · 52d
Cleared Nov 23, 1998
QUADRANT ANTERIOR SHINE
K983549 · EBF
Cavex Holland BV
Dental · 45d
Cleared Nov 23, 1998
SPECTRUM SPIRIT
K983763 · IOR
Freedom Designs, Inc.
Physical Medicine · 28d
Cleared Nov 23, 1998
MITEK FASTIN RC ANCHOR
K983818 · MBI
Mitek Products
Orthopedic · 25d
Cleared Nov 23, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
K983916 · FOZ
Hdc Corp.
General Hospital · 20d
Cleared Nov 20, 1998
URESIL VASCU-FLO INFUSION CATHETER
K980278 · DQY
Uresil Corp.
Cardiovascular · 298d
Cleared Nov 20, 1998
PERIFORM
K981277 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 226d
Cleared Nov 20, 1998
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
K981530 · BSZ
Spacelabs Medical, Inc.
Anesthesiology · 205d
Cleared Nov 20, 1998
NEUROMAP
K981820 · GZL
Radionics, Inc.
Neurology · 182d
Cleared Nov 20, 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 168d
Cleared Nov 20, 1998
STERI-PAK BOWIE DICK TEST PACK
K982188 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 151d
Cleared Nov 20, 1998
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
K982759 · DIO
OraSure Technologies, Inc.
Toxicology · 106d
Cleared Nov 20, 1998
ZETA MULTIZONE LOCKING NAIL SYSTEM
K982958 · HSB
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 20, 1998
POLYMER THREADED ANCHOR / SUTURE COMBINATION
K982963 · JDI
Orthopaedic Biosystems, Ltd.
Orthopedic · 88d
Cleared Nov 20, 1998
SYSTEM U3 FOR GENTAMICIN
K983252 · JWY
Ab Biodisk North America, Inc.
Microbiology · 65d
Cleared Nov 20, 1998
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
K983253 · LCP
Medisense, Inc.
Hematology · 65d
Cleared Nov 20, 1998
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
K983307 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 60d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T4
K983417 · CEC
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TOTAL T3
K983434 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T3
K983439 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TSH
K983442 · JLW
Abbott Laboratories
Chemistry · 51d