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

5,277 results for "health"
1297–1320 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 13, 2018
Sterile Latex Surgical Gloves, Powder Free
K171550 · KGO
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 413d
Cleared Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
K171274 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 437d
Cleared Jun 27, 2018
uDR 592h, uDR 596i
K181413 · KPR
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Jun 27, 2018
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with...
K180646 · LZC
Halyard Health
General Hospital · 107d
Cleared Jun 22, 2018
OSOM Mono Test
K181436 · KTN
SEKISUI Diagnostics, LLC
Microbiology · 21d
Cleared Jun 21, 2018
Eclipse II
K180809 · MQB
Carestream Health, Inc.
Radiology · 85d
Cleared Jun 21, 2018
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
K173028 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 266d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Innovative Health, LLC
Cardiovascular · 92d
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 15, 2018
Fusion Bx 2.0
K181290 · LLZ
Focal Healthcare, Inc.
Radiology · 30d
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 14, 2018
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent...
K180738 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 13, 2018
HealthCCS
K172983 · JAK
Zebra Medical Vision, Ltd.
Radiology · 259d
Not Cleared Jun 12, 2018
DreaMed Advisor Pro
DEN170043 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 299d
Cleared Jun 06, 2018
uMR 560
K180926 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Jun 06, 2018
uMR 570
K180925 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · NDY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 31d
Cleared May 24, 2018
McKesson Cardiology
K181080 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 30d
Cleared May 18, 2018
The IQoolTM Warm System
K180375 · DWJ
Braincool AB
Cardiovascular · 95d
Cleared May 16, 2018
Low Dose CT Lung Cancer Screening Option
K180901 · JAK
Hitachi Healthcare Americas
Radiology · 40d
Cleared May 14, 2018
Clarius Ultrasound Scanner
K180799 · IYN
Clarius Mobile Health Corp.
Radiology · 48d
Cleared May 14, 2018
Pristina Serena
K173576 · MUE
Ge Healthcare
Radiology · 175d
Cleared May 11, 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · FRN
Baxter Healthcare Corporation
General Hospital · 224d