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"
985–1008 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue...
K200671 · LZA
Ansell Healthcare Products, LLC
General Hospital · 98d
Cleared Jun 18, 2020
Andorate Biopsy Valve, Andorate Biopsy Irrigator
K200481 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 112d
Cleared Jun 12, 2020
Full Automatic(NIBP) Blood Pressure Monitor
K200521 · DXN
Health & Life Co., Ltd.
Cardiovascular · 102d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 05, 2020
Spire Health Remote Patient Monitoring System
K192952 · MSX
Spire, Inc. D/B/A Spire Health
Cardiovascular · 228d
Cleared Jun 04, 2020
Livongo Blood Glucose Monitoring System (BG1000)
K200277 · NBW
Livongo Health, Inc.
Chemistry · 121d
Cleared Jun 03, 2020
QLAB Advanced Quantification Software
K200974 · QIH
Philips Health Care
Radiology · 51d
Cleared Jun 02, 2020
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora...
K200089 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Shanghai United Imaging Healthcare...
Radiology · 255d
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