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
34177–34200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2015
Fusion Black Powder-Free Nitrile Exam Glove
K150113 · LZA
Halyard Health
General Hospital · 149d
Cleared Jun 18, 2015
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue),...
K150340 · LZA
Hebei Hongsen Plastics Technology Co,...
General Hospital · 127d
Cleared Jun 18, 2015
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with...
K150369 · PLC
Somnomed, Inc.
Dental · 125d
Cleared Jun 18, 2015
Nanova Flowable Composite
K150623 · EBF
Nanova Biomaterials, Inc.
Dental · 99d
Cleared Jun 18, 2015
Safety Disposable Insulin Syringe
K150758 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 87d
Cleared Jun 18, 2015
XIDF-AWS801, Angio Workstation, V6.10
K150967 · OWB
Toshibamedical Systems Corporation
Radiology · 66d
Cleared Jun 18, 2015
LOGIQ e
K151028 · IYN
GE Medical Systems Ultrasound and...
Radiology · 62d
Cleared Jun 18, 2015
DePuy Synthes T-PAL Ti Spacer
K151276 · MAX
Synthes USA Products, LLC
Orthopedic · 36d
Cleared Jun 18, 2015
Spacemaker Pro Access and Dissector System
K151356 · GCJ
Covidien, LLC
General & Plastic Surgery · 29d
Cleared Jun 17, 2015
ZIBONE ZIRCONIA BLOCKS
K140836 · EIH
Coho Technology Co., Ltd.
Dental · 441d
Cleared Jun 17, 2015
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
K141084 · FTM
Acell, Inc.
General & Plastic Surgery · 415d
Cleared Jun 17, 2015
BELIMED STEAM STERILIZER MST-H
K141879 · FLE
Sauter AG
General Hospital · 341d
Cleared Jun 17, 2015
Urinary Incontinence System
K142369 · KPI
Guangzhou Finecure Medical Equipment...
Gastroenterology & Urology · 296d
Cleared Jun 17, 2015
ABL800 FLEX with AQURE connectivity
K142898 · CHL
Radiometer Medical Aps
Chemistry · 254d
Cleared Jun 17, 2015
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial...
K142934 · EOQ
Covidien
Ear, Nose, Throat · 251d
Cleared Jun 17, 2015
dynaMX Compression Staple
K143622 · JDR
Mx Orthopedics, Corp.
Orthopedic · 177d
Cleared Jun 17, 2015
VS3-IR-MMS System
K150018 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 163d
Cleared Jun 17, 2015
PALACOS R pro
K150119 · LOD
Heraeus Medical GmbH
Orthopedic · 148d
Cleared Jun 17, 2015
Vdrive system, Vdrive Duo, Vdrive with V-Sono
K150312 · DXX
Stereotaxis, Inc.
Cardiovascular · 128d
Cleared Jun 17, 2015
STAR 90
K150512 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 110d
Cleared Jun 17, 2015
True Dilatation Balloon Valvuloplasty Catheter
K150667 · OZT
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Jun 17, 2015
ProTrack RF Anchor Wire
K150709 · DXF
Baylis Medical Company, Inc.
Cardiovascular · 90d
Cleared Jun 17, 2015
ARDO Calypso Pro Powered Breast Pump
K150721 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 90d
Cleared Jun 17, 2015
ESTECEM
K150727 · EMA
Tokuyama Dental Corporation
Dental · 89d