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"
697–720 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 29, 2022
Monarch Platform, Urology
K213334 · FGB
Auris Health, Inc.
Gastroenterology & Urology · 205d
Cleared Apr 27, 2022
Philips Incisive CT
K212441 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 266d
Cleared Apr 22, 2022
HealthOST
K213944 · JAK
Nanoxai , Ltd.
Radiology · 126d
Cleared Apr 22, 2022
ATUSA™ Automated 3D Breast Ultrasound System
K213620 · IYO
Isono Health, Inc.
Radiology · 157d
Cleared Apr 22, 2022
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K212031 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 297d
Cleared Apr 21, 2022
Videa Caries Assist
K213795 · MYN
Videahealth, Inc.
Radiology · 136d
Cleared Apr 15, 2022
AI-Rad Companion Brain MR
K213706 · QIH
Siemens Healthcare GmbH
Radiology · 142d
Cleared Apr 13, 2022
CARESCAPE B450, E-musb
K213363 · MHX
GE Healthcare Finland Oy
Cardiovascular · 183d
Cleared Apr 13, 2022
Carescape B850, E-musb
K213336 · MHX
GE Healthcare Finland Oy
Cardiovascular · 189d
Cleared Apr 13, 2022
CARESCAPE B650, E-musb
K213181 · MHX
GE Healthcare Finland Oy
Cardiovascular · 196d
Cleared Apr 01, 2022
SKANRAD 400
K220518 · KPR
Skanray Technologies Limited
Radiology · 37d
Cleared Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
K212216 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 259d
Cleared Mar 28, 2022
SancDam Latex Oral Dam
K212037 · MSC
Sanctuary Health Sdn. Bhd.
Obstetrics & Gynecology · 271d
Cleared Mar 24, 2022
Surgical Face Mask
K202903 · FXX
Rizhao Sanqi Medical & Health...
General Hospital · 541d
Cleared Mar 23, 2022
DRX-Rise Mobile X-ray System
K213568 · IZL
Carestream Health
Radiology · 134d
Cleared Mar 18, 2022
Merits P335 Powered Wheelchair
K220529 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 22d
Cleared Mar 18, 2022
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use...
K220228 · LZA
Shandong Blue Sail Health Technology...
General Hospital · 50d
Cleared Mar 18, 2022
15L Cycler Drainage Bag
K214016 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 86d
Cleared Mar 18, 2022
F&P Evora Full Face Mask
K212371 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Mar 10, 2022
Smile-100 System
K212965 · LHQ
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
K212165 · PNE
Innovative Health, LLC
Cardiovascular · 241d
Cleared Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for...
K212148 · LZA
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 08, 2022
Medical Face Mask
K214087 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 71d
Cleared Mar 04, 2022
Skanmobile, Skanmobile-Dr
K212940 · IZL
Skanray Technologies Limited
Radiology · 170d