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"
1249–1272 of 5,277
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 25, 2018
External upper limb tremor stimulator
K182706 · QBC
Cala Health, Inc.
Neurology · 28d
Cleared Oct 25, 2018
PeekMed
K182464 · LLZ
Peek Health, S.A.
Radiology · 45d
Cleared Oct 23, 2018
JiveX
K181964 · LLZ
Visus Health IT GmbH
Radiology · 92d
Cleared Oct 22, 2018
Comarch e-Care Platform
K181248 · DRG
Comarch Healthcare SA
Cardiovascular · 165d
Cleared Oct 19, 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590 · MOS
Ge Healthcare
Radiology · 29d
Cleared Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · NLH
Innovative Health, LLC
Cardiovascular · 121d
Cleared Oct 17, 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · DXN
Health & Life Co., Ltd.
Cardiovascular · 261d
Cleared Oct 12, 2018
3.0T Air MP M, 3.0T Air MP L
K182504 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 30d
Cleared Oct 12, 2018
uMI 550 PET/CT System
K182237 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Oct 03, 2018
uMR 790
K181371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
uMR 780
K181370 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 02, 2018
Infrared Ear Thermometer
K181081 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 161d
Cleared Sep 28, 2018
Acessa ProVu System
K181124 · HFG
Acessa Health, Inc.
Obstetrics & Gynecology · 151d
Cleared Sep 26, 2018
NxStage Connected Health System
K181991 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 25, 2018
IBM iConnect Access
K182290 · LLZ
Merge Healthcare Incorporated
Radiology · 33d
Cleared Sep 25, 2018
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag...
K181692 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 90d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714 · FLL
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Sep 21, 2018
Volpara Imaging Software
K182310 · LLZ
Volpara Health Technologies Limited
Radiology · 28d
Cleared Sep 21, 2018
Pocket Colposcope System
K181034 · HEX
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology · 156d
Cleared Sep 20, 2018
LOGIQ P9
K181783 · IYN
Ge Healthcare
Radiology · 79d
Cleared Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 27d
Cleared Sep 07, 2018
syngo.via View&GO (Version VA10A)
K182208 · LLZ
Siemens Healthcare GmbH
Radiology · 23d
Cleared Sep 07, 2018
INNOVANCE Free PS Ag
K181525 · GGP
Siemens Healthcare Diagnostics...
Hematology · 88d
Cleared Aug 31, 2018
ALTAPORE
K181225 · MQV
Baxter Healthcare Corporation
Orthopedic · 115d