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

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175,820 results
15553–15576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2021
AURORA Evacuator +Coag
K203745 · GEI
Rebound Therapeutics
Neurology · 345d
Cleared Dec 02, 2021
Encevis
K211452 · OMB
Austrian Institute of Technology GmbH
Neurology · 206d
Cleared Dec 02, 2021
PS System
K211721 · NYL
Inter-Med, Inc.
Dental · 181d
Cleared Dec 02, 2021
Single-use Surgical Mask
K211773 · FXX
Taiwan Seafood and Fish Corporation
General Hospital · 177d
Cleared Dec 02, 2021
Clivia series Diagnostic Ultrasound System
K211886 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 164d
Cleared Dec 02, 2021
Nitrile disposable examination gloves
K212578 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 108d
Cleared Dec 02, 2021
Puravita Medical Fold Flat Surgical Mask
K212740 · FXX
Puravita M, LLC
General Hospital · 94d
Cleared Dec 02, 2021
powder free nitrile examination glove - white, non-sterile
K212802 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 91d
Cleared Dec 02, 2021
Aimanfun Lumea Comfort, A-2789/A-3588
K212907 · ONF
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 80d
Cleared Dec 02, 2021
FUJIFILM Video Laparoscope EL-R740M30
K212950 · GCJ
Fujifilm Corporaton
General & Plastic Surgery · 77d
Cleared Dec 01, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
K210934 · KNS
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 247d
Cleared Dec 01, 2021
Electric Breast Pump
K211755 · HGX
Zhejiang Carebao Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Dec 01, 2021
Milli Vaginal Dilator
K211959 · HDX
Materna Medical
Obstetrics & Gynecology · 160d
Cleared Dec 01, 2021
NGM WAVE PLIF Cage
K212050 · MAX
NGMedical GmbH
Orthopedic · 154d
Cleared Dec 01, 2021
AC Cream - Conductive paste
K212326 · GYB
Spes Medica Srl
Neurology · 128d
Cleared Dec 01, 2021
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212789 · LZA
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 91d
Cleared Dec 01, 2021
Powder free nitrile examination glove- blue, non-sterile
K212804 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 90d
Cleared Dec 01, 2021
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
K212864 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 84d
Cleared Dec 01, 2021
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit...
K213305 · LNH
Canon Medical Systems Corporation
Radiology · 58d
Cleared Nov 30, 2021
ARROW Short Stem Humeral System
K202024 · PHX
FH Industrie
Orthopedic · 496d
Cleared Nov 30, 2021
Paltop Narrow Implant
K210117 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 315d
Cleared Nov 30, 2021
InstruSafe Instrument Protection System
K210836 · KCT
Summitt Medical, LLC
General Hospital · 253d
Cleared Nov 30, 2021
KardiaMobile Card
K211668 · DXH
AliveCor, Inc.
Cardiovascular · 182d
Cleared Nov 30, 2021
Disposable Surgical Face Mask
K211696 · FXX
Anhui Cleanpro Pharmpack Co., Ltd.
General Hospital · 181d