FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
24649–24672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2018
GastroFlush
K180605 · KNT
Bionix Development Corporation
Gastroenterology & Urology · 231d
Cleared Oct 24, 2018
Osteocera Resorbable Bone Substitute
K180758 · MQV
Wiltrom Corporation Limited
Orthopedic · 216d
Cleared Oct 24, 2018
Gas Module 3
K180788 · BZK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 212d
Cleared Oct 24, 2018
KODEX EPD System
K180940 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 197d
Cleared Oct 24, 2018
World Total Knee System
K181530 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 135d
Cleared Oct 24, 2018
Cios Alpha
K181560 · OWB
Siemens Medical Systems USA, Inc.
Radiology · 132d
Cleared Oct 24, 2018
Spine Wave Navigated Instruments
K181596 · OLO
Spine Wave, Inc.
Orthopedic · 128d
Cleared Oct 24, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K182140 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 78d
Cleared Oct 24, 2018
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT...
K182281 · IYO
C. R. Bard
Radiology · 62d
Cleared Oct 24, 2018
Retina Workplace
K182318 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 58d
Cleared Oct 24, 2018
Duo Lumbar Interbody Fusion Device
K182322 · MAX
Spineology, Inc.
Orthopedic · 58d
Cleared Oct 24, 2018
TempSure System
K182365 · GEI
Cynosure, Inc.
General & Plastic Surgery · 55d
Cleared Oct 24, 2018
GC70
K182647 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Oct 23, 2018
BD Single Use, Hypodermic Syringe
K172670 · FMF
Becton, Dickinson and Company
General Hospital · 413d
Cleared Oct 23, 2018
Humeral Short Stem System
K173824 · MBF
Shoulder Innovations, Inc.
Orthopedic · 309d
Cleared Oct 23, 2018
Masimo Rad-97 and Accessories
K180046 · DQA
Masimo Corporation
Anesthesiology · 288d
Cleared Oct 23, 2018
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
K180622 · KNT
Covidien
Gastroenterology & Urology · 228d
Cleared Oct 23, 2018
JiveX
K181964 · LLZ
Visus Health IT GmbH
Radiology · 92d
Cleared Oct 23, 2018
Cumulus Remover
K182002 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 89d
Cleared Oct 23, 2018
Randox Calcium (Ca)
K182042 · CJY
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Oct 23, 2018
BTL 799-2T
K182106 · NGX
BTL Industries, Inc.
Physical Medicine · 81d
Cleared Oct 23, 2018
FUSE Pedicle Screw System
K182283 · NKB
Black Box Medical
Orthopedic · 61d
Cleared Oct 23, 2018
Xperius Ultrasound System
K182529 · IYN
Philips Ultrasound, Inc.
Radiology · 39d
Cleared Oct 23, 2018
GU60A, GU60A-65
K182622 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d