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
25033–25056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2018
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
K181368 · NGZ
bioMerieux, Inc.
Microbiology · 28d
Cleared Jun 19, 2018
sterEOS Workstation
K172346 · LLZ
Eos Imaging
Radiology · 320d
Cleared Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
K173139 · NBW
Bionime Corporation
Chemistry · 263d
Cleared Jun 19, 2018
SpeedBird Model SB38 Soft Tissue Biopsy Device
K173316 · KNW
Transmed7, LLC
Gastroenterology & Urology · 243d
Cleared Jun 19, 2018
PICOPLUS Laser System
K173700 · GEX
Lutronic Corporation
General & Plastic Surgery · 197d
Cleared Jun 19, 2018
Surgic Pro, Surgic Pro+
K173905 · EBW
Nakanishi, Inc.
Dental · 179d
Cleared Jun 19, 2018
ViSi Mobile Monitoring System
K180472 · MHX
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Innovative Health, LLC
Cardiovascular · 92d
Cleared Jun 19, 2018
Neutrogena Light Therapy Acne Mask+
K180847 · OLP
Johnson & Johnson Consumer, Inc.
General & Plastic Surgery · 78d
Cleared Jun 19, 2018
Neutrogena Light Therapy Aging Mask+
K180856 · OHS
Johnson & Johnson Consumer, Inc.
General & Plastic Surgery · 78d
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 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