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
78145–78168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2001
SUPERIOR BATH, MODEL 6300
K012061 · ILJ
Penner Manufacturing, Inc.
Physical Medicine · 17d
Cleared Jul 18, 2001
VIVO 200 DPS VIVOSCAN
K003364 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 264d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · MQP
United States Surgical, A Division of...
Orthopedic · 229d
Cleared Jul 18, 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681 · KWP
Depuyacromed
Orthopedic · 133d
Cleared Jul 18, 2001
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
K011206 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 18, 2001
PVC FREE INTRAVASCULAR ADMINISTRATION SET
K011216 · FPA
Biometrix , Ltd.
General Hospital · 89d
Cleared Jul 18, 2001
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K011312 · CBF
Khrunichev State Research &...
Anesthesiology · 79d
Cleared Jul 18, 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · JDI
Biomet, Inc.
Orthopedic · 68d
Cleared Jul 18, 2001
UROLOGICAL CATHETER
K011552 · GBM
Apogee Medical, Inc.
Gastroenterology & Urology · 61d
Cleared Jul 18, 2001
ADMIRA FLOW
K011756 · EBF
Voco GmbH
Dental · 42d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jul 18, 2001
OIL FOR EMBRYO CULTURE
K011938 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 27d
Cleared Jul 18, 2001
IVENT 201 PORTABLE VENTILATOR
K011957 · CBK
Versamed , Ltd.
Anesthesiology · 26d
Cleared Jul 18, 2001
1.5MM BONE FIXATION KIT
K012000 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
SMARTSCREW
K012001 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026 · JDI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jul 17, 2001
WUNDCATH CONDUCTION CATHETER
K003966 · FRN
Micor, Inc.
General Hospital · 207d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112 · DLJ
Dade Behring, Inc.
Chemistry · 97d
Cleared Jul 17, 2001
TORIC LITE LENS
K011256 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 84d
Cleared Jul 17, 2001
MESH URETERAL STENT
K011264 · FAD
Applied Medical Resources Corp.
Gastroenterology & Urology · 83d
Cleared Jul 17, 2001
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K011456 · MRC
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 67d
Cleared Jul 17, 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 63d
Cleared Jul 17, 2001
AMERITEK BRACHYTHERAPY TEMPLATE
K011581 · ITX
Amertek Medical, Inc.
Radiology · 55d
Cleared Jul 17, 2001
UREA NITROGEN (BUN) LIQUID REAGENT
K011596 · CDQ
Jas Diagnostic, Inc.
Chemistry · 54d