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

5,276 results for "health"
1177–1200 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Apr 05, 2019
OJR215 Pressure Relief Manifold
K173770 · CBP
Fisher & Paykel Healthcare Limited
Anesthesiology · 480d
Cleared Apr 02, 2019
ARIETTA 50
K190248 · IYN
Hitachi Healthcare Americas
Radiology · 54d
Cleared Mar 29, 2019
Loop System
K181352 · DQA
Spry Health, Inc.
Cardiovascular · 311d
Cleared Mar 27, 2019
Wearable Device, Home Package in Carry Case with Homehub, Home Package in...
K190073 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Mar 25, 2019
InTouch Thermal Camera
K181716 · LHQ
Intouch Technologies, Inc., D.B.A....
Radiology · 270d
Cleared Mar 22, 2019
uWS-MR
K183164 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 127d
Cleared Mar 22, 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · KGO
Ansell Healthcare Products, LLC
General Hospital · 150d
Cleared Mar 22, 2019
ON-Q* Pump with Bolus
K181360 · MEB
Halyard Health
General Hospital · 304d
Cleared Mar 20, 2019
ACUSON S3000, S2000 Diagnostic Ultrasound System
K183575 · IYN
Siemens Healthineers
Radiology · 89d