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
74953–74976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · HCG
Boston Scientific, Target
Neurology · 28d
Cleared Jun 06, 2002
OSCAR, MODEL OE3000
K021502 · LZV
Orthosonics, Ltd.
Orthopedic · 28d
Cleared Jun 06, 2002
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K021506 · LZA
Shijiazhuang Great Vision Plastic...
General Hospital · 28d
Cleared Jun 06, 2002
PAINDOC
K021518 · GZB
Advanced Neuromodulation Systems
Neurology · 27d
Cleared Jun 06, 2002
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K021519 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Jun 06, 2002
VAXCEL PICC WITH PASV VALVE TECHNOLOGY
K021704 · LJS
Catheter Innovations, Inc.
General Hospital · 14d
Cleared Jun 05, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
K013654 · JJF
Precision Systems, Inc.
Toxicology · 211d
Cleared Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
K013902 · IYN
U-Systems, Inc.
Radiology · 191d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772 · KTT
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jun 05, 2002
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
K020779 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 86d
Cleared Jun 05, 2002
ENDOSCOPIC LIGHT SOURCE XL202/L3
K020889 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 78d
Cleared Jun 05, 2002
VACURECT VACUUM CONSTRICTION DEVICE
K020969 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 71d
Cleared Jun 05, 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · KRO
Biomet, Inc.
Orthopedic · 47d
Cleared Jun 05, 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · JWH
Biomet, Inc.
Orthopedic · 23d
Cleared Jun 05, 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584 · DZE
Nobel Biocare Uas, Inc.
Dental · 22d
Cleared Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621 · HRY
Biomet, Inc.
Orthopedic · 20d
Cleared Jun 05, 2002
PHYSICIAN'S DESKTOP REVIEW
K021669 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Jun 04, 2002
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
K010132 · DZE
SOADCO, S.L.
Dental · 504d
Cleared Jun 04, 2002
PHYSIOLOG, SERIES 95000
K013032 · DQK
Camtronics, Ltd.
Cardiovascular · 267d
Cleared Jun 04, 2002
HYPERION VISIQUANT ANA TEST KIT
K013213 · DHN
Hyperion, Inc.
Immunology · 251d
Cleared Jun 04, 2002
SILICONE TRACHEAL T-TUBES
K013321 · BTR
Technical Products, Inc.
Anesthesiology · 242d
Cleared Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · JGS
Phoenix Diagnostics, Inc.
Chemistry · 120d
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · DJG
Lin-Zhi International, Inc.
Toxicology · 120d
Cleared Jun 04, 2002
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K020389 · MVN
Ocular Sciences
Ophthalmic · 119d