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

5,275 results for "health"
745–768 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Mar 03, 2022
Air Compression Leg Massager (model: FE-7204B)
K211850 · IRP
Xiamen Healthpal Electronic Co.,Ltd
Physical Medicine · 261d
Cleared Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
K212379 · DFH
Siemens Healthcare Diagnostics...
Immunology · 212d
Cleared Mar 01, 2022
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,...
K213400 · NUC
Rb Health (Us)
Obstetrics & Gynecology · 134d
Cleared Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
K213189 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 153d
Cleared Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
K211484 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 293d
Cleared Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135 · FRO
3M Healthcare Business Group
General & Plastic Surgery · 401d
Cleared Feb 19, 2022
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For...
K214110 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 52d
Cleared Feb 19, 2022
Well-Life TENS/EMS/Heating Stimulator
K213091 · NUH
Well-Life Healthcare Limited
Neurology · 148d
Cleared Feb 19, 2022
Heartland Health Surgical Mask
K212366 · FXX
Heartland Health Products
General Hospital · 204d