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
79585–79608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · HBC
Aesculap, Inc.
Neurology · 90d
Cleared Feb 20, 2001
PLGA PIN, MODEL...
K003659 · HTY
Bionx Implants, Inc.
Orthopedic · 84d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · HWC
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · GJS
Dade Behring, Inc.
Hematology · 67d
Cleared Feb 20, 2001
TOTAL BILIRUBIN REAGENT
K003892 · CIG
Intersect Systems, Inc.
Chemistry · 64d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Dade Behring, Inc.
Chemistry · 28d
Cleared Feb 16, 2001
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
K001916 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 238d
Cleared Feb 16, 2001
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K002045 · FIP
Total Water Treatment Systems, Inc.
Gastroenterology & Urology · 226d
Cleared Feb 16, 2001
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90,...
K002054 · DYB
Appriva Medical, Inc.
Cardiovascular · 225d
Cleared Feb 16, 2001
ACTICOAT COMPOSITE DRESSING
K002466 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 189d
Cleared Feb 16, 2001
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
K002650 · FGE
Bentec Medical, Inc.
Gastroenterology & Urology · 175d
Cleared Feb 16, 2001
REGUTHERM 952 THERMOGRAPHIC SYSTEM
K003130 · LHQ
Sie-Med, Inc.
Radiology · 133d
Cleared Feb 16, 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · FYA
Medline Industries, Inc.
General Hospital · 73d
Cleared Feb 16, 2001
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
K003932 · HQD
Polymer Technology
Ophthalmic · 58d
Cleared Feb 16, 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
K003933 · MUW
Polymer Technology
Ophthalmic · 58d
Cleared Feb 16, 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P,...
K010135 · INI
Invacare Corp.
Physical Medicine · 30d
Cleared Feb 16, 2001
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
K010297 · LZA
Maxxim Medical
General Hospital · 16d
Cleared Feb 16, 2001
ADVANTAGE WINDOWS CT/PET FUSION
K010336 · LLZ
Ge Medical Systems, Inc.
Radiology · 11d
Cleared Feb 15, 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147 · JWH
Howmedica Osteonics Corp.
Orthopedic · 311d
Cleared Feb 15, 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · MAI
Mitek Products
Orthopedic · 192d
Cleared Feb 15, 2001
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
K002596 · MLY
Gebauer Co.
Physical Medicine · 178d
Cleared Feb 15, 2001
PARIETEX COMPOSITE (PCO) MESH
K002699 · FTL
Medical Device Consultants, Inc.
General & Plastic Surgery · 169d
Cleared Feb 15, 2001
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549 · JEY
Codman & Shurtleff, Inc.
Dental · 90d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Smith & Nephew, Inc.
Orthopedic · 87d