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
25633–25656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2018
Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
K181389 · GEI
Covidien
General & Plastic Surgery · 25d
Cleared Jun 18, 2018
IU Implant System
K172345 · DZE
Warantec Co., Ltd.
Dental · 320d
Cleared Jun 18, 2018
GCE704 Breast Pump
K172842 · HGX
Globalcare
Obstetrics & Gynecology · 272d
Cleared Jun 18, 2018
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816,...
K172895 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 269d
Cleared Jun 18, 2018
Sherlock 3CG+ T ip Confirmation System
K180560 · LJS
C.R. Bard, Inc.
General Hospital · 109d
Cleared Jun 18, 2018
Savion DLVR Guidewire, Savion FLX Guidewire
K180726 · DQX
Boston Scientific, Inc.
Cardiovascular · 90d
Cleared Jun 18, 2018
SD LTM STIM Cortical Stimulator
K180761 · GYC
Micromed S.P.A.
Neurology · 87d
Cleared Jun 18, 2018
Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral...
K181484 · EBF
Zirkonzahn Srl
Dental · 13d
Cleared CT Jun 17, 2018
FlowTriever Retrieval/Aspiration System
K181325 · QEW
Inari Medical, Inc.
Cardiovascular · 30d
Cleared Jun 15, 2018
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro...
K170835 · EGJ
Hightech Development
Physical Medicine · 452d
Cleared Jun 15, 2018
Trinity PLUS Acetabular Shell
K172551 · LPH
Corin U.S.A. Limited
Orthopedic · 296d
Cleared Jun 15, 2018
Medline Prevention CoolZone Gown
K172954 · FYA
Medline Industries, Inc.
General Hospital · 262d
Cleared Jun 15, 2018
Interlude and private label Unscented 3-piece compact applicator tampon
K173225 · HEB
Albaad Fem
Obstetrics & Gynecology · 255d
Cleared Jun 15, 2018
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
K173507 · LNH
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 214d
Cleared Jun 15, 2018
DESS Dental Smart Solutions
K173908 · NHA
Terrats Medical SL
Dental · 175d
Cleared Jun 15, 2018
Natus Photic Stimulator
K173936 · GWE
Natus Medical Incorporated Dba...
Neurology · 171d
Cleared Jun 15, 2018
Scone Mask
K180497 · BZD
Resmed, Ltd.
Anesthesiology · 109d
Cleared Jun 15, 2018
Life Spine SIMPACT Sacroiliac Joint Fixation System
K180749 · OUR
Life Spine, Inc.
Orthopedic · 85d
Cleared Jun 15, 2018
CoLink™ Afx Plating System
K181113 · HRS
In2bones USA, LLC
Orthopedic · 49d
Cleared Jun 15, 2018
Fusion Bx 2.0
K181290 · LLZ
Focal Healthcare, Inc.
Radiology · 30d
Cleared Jun 14, 2018
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch &...
K172011 · DRG
Hmicro, Inc.
Cardiovascular · 346d
Cleared Jun 14, 2018
Access hsTnl
K172787 · MMI
Beckman Coulter, Inc.
Chemistry · 272d
Cleared Jun 14, 2018
Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil...
K172800 · MIA
Smiths Medical Asd, Inc.
Anesthesiology · 269d
Cleared Jun 14, 2018
Disposable Sterile Needle
K172938 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 261d