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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39601–39624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510 · HRS
Arthrex, Inc.
Orthopedic · 210d
Cleared Sep 25, 2013
I-GEN
K131289 · JEY
Megagen Implant Co., Ltd.
Dental · 142d
Cleared Sep 25, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K131440 · LZA
Hebei Hongsen Plastics Technology Co,...
General Hospital · 128d
Cleared Sep 25, 2013
FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
K131751 · KGO
Lucenxia Prescience AG
General Hospital · 103d
Cleared Sep 25, 2013
NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
K131873 · LLZ
MethodSense, Inc.
Radiology · 93d
Cleared Sep 25, 2013
ECLIPSE TREATMENT PLANNING SYSTEM
K131891 · MUJ
Varian Medical Systems, Inc.
Radiology · 92d
Cleared Sep 25, 2013
XVI R5.0
K131965 · IYE
Elekta Limited
Radiology · 90d
Cleared Sep 25, 2013
MULTICHEM P
K131992 · JJY
Techno-Path Manufacturing , Ltd.
Immunology · 89d
Cleared Sep 25, 2013
JAZZ SYSTEM
K132287 · OWI
Hogan Lovells US LLP
Orthopedic · 64d
Cleared Sep 25, 2013
PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC
K132665 · GEI
Ellman International, Inc.
General & Plastic Surgery · 29d
Cleared Sep 24, 2013
DIAGNOCAM
K123402 · NTK
Kaltenbach & Voigt GmbH
Dental · 323d
Cleared Sep 24, 2013
CRYSTAL ULTRA
K130654 · EIH
Dental Laboratory Milling Supplies,...
Dental · 196d
Cleared Sep 24, 2013
SHENGGUANG MANUAL WHEELCHAIR
K131529 · IOR
Pingdingshan Shenxing Healthcare...
Physical Medicine · 119d
Cleared Sep 24, 2013
GE ECHOPAC
K131685 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 106d
Cleared Sep 24, 2013
BRILLIANCE ICT
K131773 · JAK
Philips Healthcare (Cleveland)
Radiology · 99d
Cleared Sep 24, 2013
VOLUSON I/E
K131937 · IYN
Ge Healthcare
Radiology · 89d
Cleared Sep 24, 2013
AIXPLORER
K132171 · IYN
Supersonic Imagine
Radiology · 71d
Cleared Sep 24, 2013
AIXPLORER
K132274 · IYN
Supersonic Imagine
Radiology · 64d
Cleared Sep 23, 2013
BELIMED STEAM STERILIZER MST-V
K130172 · FLE
Belimed, Inc.
General Hospital · 242d
Cleared Sep 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d
Cleared Sep 23, 2013
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
K130365 · OQG
Encore Medical, L.P.
Orthopedic · 222d
Cleared Sep 23, 2013
RELIANCE CERVICAL IBF SYSTEM
K131429 · ODP
Reliance Medical Systems, LLC
Orthopedic · 129d
Cleared Sep 23, 2013
SFI-BAR
K131526 · NHA
Cendres & Metaux SA
Dental · 118d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d