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
78649–78672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2001
ENTEC EVAC PLASMA WAND
K011279 · GEI
Arthrocare Corp.
General & Plastic Surgery · 83d
Cleared Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
K011296 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 80d
Cleared Jul 19, 2001
MTP LAPAROMAT DISPOSABLE TUBING SET
K011360 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 77d
Cleared Jul 19, 2001
CAVEX STABISIL
K011452 · ELW
Cavex Holland BV
Dental · 69d
Cleared Jul 19, 2001
ENDOPOUCH RETRIEVER
K011501 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 64d
Cleared Jul 19, 2001
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · LBI
Ohmeda Medical
General Hospital · 62d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL...
K011904 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · KWP
Synthes (Usa)
Orthopedic · 24d
Cleared Jul 19, 2001
CASCADE BATH, MODEL 6900
K012057 · ILJ
Penner Manufacturing, Inc.
Physical Medicine · 17d
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