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
80113–80136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 15, 2001
ONYX-RAD TELEMEDICINE PACS
K003607 · LLZ
Viztek, Inc.
Radiology · 85d
Cleared Feb 15, 2001
PERMLASTIC 3
K003650 · ELW
Sybron Dental Specialties, Inc.
Dental · 80d
Cleared Feb 15, 2001
ACCUFUSER
K003915 · MEB
Help Technologies
General Hospital · 58d
Cleared Feb 15, 2001
NITRILE EXAMINATION GLOVES (POWERED)
K003922 · LZA
Guthrie Medicare Products (Melaka)...
General Hospital · 57d
Cleared Feb 15, 2001
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D...
K003977 · FPA
Disetronic Medical Systems AG
General Hospital · 55d
Cleared Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
K004019 · LJM
The Binding Site, Ltd.
Immunology · 50d
Cleared Feb 15, 2001
PERFECTA AND EXTEND
K004032 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 49d
Cleared Feb 15, 2001
DURABOND NON-PRECIOUS CERAMIC ALLOY
K010069 · EJH
Matech, Inc.
Dental · 38d
Cleared Feb 15, 2001
A & I WHEELCHAIRS
K010094 · IOR
Taiwan an I Co., Ltd.
Physical Medicine · 35d
Cleared Feb 15, 2001
COMFOR-CLINER
K010194 · IOR
Recliner Care, Inc.
Physical Medicine · 24d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · LZC
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Feb 15, 2001
TRI-FIT FEMORAL STEM
K010243 · LWJ
Corin USA
Orthopedic · 21d
Cleared Feb 14, 2001
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
K001329 · FPA
Lifemed of California
General Hospital · 293d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 208d