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"
1033–1056 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
K200509 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared May 15, 2020
AquaPulse Auxiliary Water Connector
K200479 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 78d
Cleared May 15, 2020
Pristina Serena Bright
K193334 · MUE
Ge Healthcare
Radiology · 165d
Cleared May 12, 2020
HealthVCF
K192901 · QFM
Zebra Medical Vision, Ltd.
Radiology · 210d
Cleared May 08, 2020
ALTAPORE SHAPE
K200640 · MQV
Baxter Healthcare Corporation
Orthopedic · 58d
Cleared May 07, 2020
Chemfort CSTD
K192866 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 213d
Cleared May 06, 2020
RFID Localization System
K193189 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 169d
Cleared May 05, 2020
uMR 780
K193176 · LNH
Shanghai United Imaging Healthcare...
Radiology · 169d
Cleared Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · QEP
Binx Health, Inc.
Microbiology · 56d
Cleared Apr 20, 2020
uMR 570
K200024 · LNH
Shanghai United Imaging Healthcare...
Radiology · 105d
Cleared Apr 20, 2020
KY Grosz Liquid
K193032 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 172d
Cleared Apr 16, 2020
Caption Guidance
K200755 · QJU
Caption Health
Radiology · 24d
Cleared Apr 15, 2020
Monarch Platform
K193534 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 117d
Cleared Apr 14, 2020
JiveX
K200703 · LLZ
Visus Health IT GmbH
Radiology · 27d
Cleared Apr 14, 2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
K200388 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 56d
Cleared Apr 14, 2020
Xelis Dental 2.0
K193369 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 131d
Cleared Apr 14, 2020
KY Grosz UltraGel
K192982 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 172d
Cleared Apr 13, 2020
ADVIA Centaur CEA Assay
K200215 · DHX
Siemens Healthcare Disgnostics, Inc.
Immunology · 76d
Cleared Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
K193573 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 109d
Cleared Apr 10, 2020
SIGNA Premier
K193282 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 135d
Cleared Apr 06, 2020
ADVIA Centaur CA 125II
K200199 · LTK
Siemens Healthcare Diagnostics, Inc.
Immunology · 70d
Cleared Mar 29, 2020
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE...
K200494 · MHX
Ge Healthcare
Cardiovascular · 30d
Cleared Mar 29, 2020
Torc Body
K192039 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 243d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d