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"
1201–1224 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 09, 2018
Heat Pain Pro
K181992 · NUH
Omron Healthcare, Inc.
Neurology · 106d
Cleared Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
K182166 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 07, 2018
uWS-CT
K173001 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 07, 2018
uWS-MR
K172999 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K181403 · OWB
Ge Healthcare
Radiology · 157d
Cleared Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · DFH
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d
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