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

5,198 results for "health"
817–840 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 08, 2021
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
K211127 · DXN
Health & Life Co., Ltd.
Cardiovascular · 145d
Cleared Sep 03, 2021
WoundExpress
K211200 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 134d
Cleared Sep 03, 2021
Current Health Monitoring System Gen 2 (G2)
K210133 · MSX
Current Health
Cardiovascular · 227d
Cleared Sep 01, 2021
Welspun Health Surgical Mask
K211536 · FXX
Welspun India Limited
General Hospital · 106d
Cleared Aug 31, 2021
Adhesive Electrode
K210448 · GXY
Shaoxing Yingtuo Healthcare Co., Ltd.
Neurology · 196d
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390 · LZA
Cardinal Health200, LLC
General Hospital · 115d
Cleared Aug 27, 2021
MyoSPECT, MyoSpect ES
K212004 · KPS
Ge Healthcare
Radiology · 60d
Cleared Aug 27, 2021
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN
Ge Healthcare
Radiology · 102d
Not Cleared Aug 27, 2021
Canary Tibial Extension with Canary Health Implanted Reporting Processor...
DEN200064 · QPP
Canary Medical, Inc.
Orthopedic · 312d
Cleared Aug 26, 2021
Visby Medical Sexual Health
K200748 · QEP
Visby Medical
Microbiology · 521d
Cleared Aug 25, 2021
Diagnostic X-ray System/PLX5200A
K212134 · IZL
Nanjing Perlove Medical Equipment...
Radiology · 48d
Cleared Aug 24, 2021
SKR 3000
K210619 · MQB
Konica Minolta, Inc.
Radiology · 176d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB
Siemens Healthcare Diagnostics, Inc.
Chemistry · 603d
Cleared Aug 17, 2021
Disposable Medical Nitrile Gloves
K211708 · LZA
Jiangsu Health-Peace Medical...
General Hospital · 75d
Cleared Aug 16, 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · LZA
Rhino Health, Inc.
General Hospital · 286d
Cleared Aug 13, 2021
Insignis Subcutaneous Needle Sets
K202279 · FPA
Innovative Health Sciences, LLC
General Hospital · 367d
Cleared Aug 11, 2021
Medical Face Mask
K211353 · FXX
Shenzhen Lyttop Healthcare Limited
General Hospital · 100d
Cleared Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
K203448 · JAK
Shanghai United Imaging Healthcare...
Radiology · 261d
Cleared Aug 06, 2021
Senographe Pristina
K211725 · MUE
Ge Healthcare
Radiology · 63d
Cleared Aug 04, 2021
PrevisEA Device
K211068 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 137d
Cleared Jul 29, 2021
Hemafuse System
K210862 · CAC
Sisu Global Health
Cardiovascular · 128d
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 136d
Cleared Jul 29, 2021
FiteBac CC OrthoSeal
K210115 · DYH
Largent Health, LLC
Dental · 191d