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"
1129–1152 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 13, 2019
HealthICH
K190424 · QAS
Zebra Medical Vision, Ltd.
Radiology · 111d
Cleared Jun 13, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
K190133 · DXN
Health & Life Co., Ltd.
Cardiovascular · 136d
Not Cleared Jun 07, 2019
IB-Stim
DEN180057 · QHH
Innovative Health Solutions (Ihs), Inc.
Neurology · 225d
Cleared Jun 04, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183535 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared May 29, 2019
uMR 780, uMR 790
K191157 · LNH
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared May 28, 2019
Clearlink System Solution Set
K180739 · FPA
Baxter Healthcare Corporation
General Hospital · 432d
Cleared May 27, 2019
Surgical Face Mask
K182515 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
K190077 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 128d
Cleared May 23, 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with...
K190018 · KGO
Ansell Healthcare Products, LLC
General Hospital · 139d
Cleared May 20, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
K190134 · DXN
Health & Life Co., Ltd.
Cardiovascular · 112d
Cleared May 17, 2019
DRX-Revolution Mobile X-ray System
K191025 · IZL
Carestream Health, Inc.
Radiology · 29d
Cleared May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 63d
Cleared May 17, 2019
KY Banksy Moisture
K183505 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 150d
Cleared May 16, 2019
syngo.via (Version VB40A)
K191040 · LLZ
Siemens Healthcare GmbH
Radiology · 27d
Cleared May 16, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183534 · DXN
Andon Health Co, Ltd.
Cardiovascular · 148d
Cleared May 06, 2019
HealthPNX
K190362 · QFM
Zebra Medical Vision, Ltd.
Radiology · 80d
Cleared May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
K190879 · DFH
Siemens Healthcare Diagnostics...
Immunology · 29d
Cleared May 01, 2019
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
K183394 · CCK
GE Healthcare Finland Oy
Anesthesiology · 145d
Cleared Apr 26, 2019
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830 · QPC
Cardinal Health200, LLC
General Hospital · 203d
Cleared Apr 23, 2019
Reprocessed Supreme Diagnostic Electrophysiology Catheter
K182386 · DRF
Innovative Health, LLC
Cardiovascular · 231d
Cleared Apr 17, 2019
HEM-6410T-ZL Wrist Blood Pressure Monitor
K190693 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Apr 16, 2019
KY Banksy Aloe
K183302 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 140d
Cleared Apr 16, 2019
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native...
K181541 · MWI
Andon Health Co, Ltd.
Cardiovascular · 309d
Cleared Apr 09, 2019
Vera
K182333 · LXJ
Reflexion Health, Inc.
Physical Medicine · 224d