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"
865–888 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 10, 2021
Surgical Masks, Model:FE-1
K210767 · FXX
Hunan Triplex Precision Medical...
General Hospital · 87d
Cleared Jun 10, 2021
Blood Administration Set
K210335 · BRZ
Baxter Healthcare Corporation
General Hospital · 125d
Cleared Jun 08, 2021
Medical Face Mask
K211062 · FXX
Ammex-Weida (Hubei) Health and Safety...
General Hospital · 60d
Cleared Jun 07, 2021
Surgical Face Mask (Ear loops and Tie-on)
K210433 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 115d
Cleared Jun 07, 2021
Disposable Surgical Mask
K210372 · FXX
Dongguan Shin YI Healthcare Products...
General Hospital · 119d
Cleared Jun 04, 2021
Surgical face mask
K203704 · FXX
Juntech(Jiaxing)Healthcare Materials...
General Hospital · 168d
Cleared Jun 04, 2021
Kendall NPWT Incision Management Device
K202217 · OMP
Cardinalhealth
General & Plastic Surgery · 302d
Cleared Jun 01, 2021
Well-Life Garment Electrodes (GM Series)
K200942 · GXY
Well-Life Healthcare Limited
Neurology · 419d
Cleared May 21, 2021
Universal Viewer
K211312 · LLZ
Ge Healthcare
Radiology · 21d
Cleared May 18, 2021
Personal Lubricant Jelly
K202667 · NUC
Nantong Health & Beyond Hygienic...
Obstetrics & Gynecology · 246d
Cleared May 06, 2021
Dr. Yglo Wart Remover
K210529 · GEH
Theotclab Healthcare B.V.
General & Plastic Surgery · 72d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K203655 · NLH
Innovative Health, LLC
Cardiovascular · 140d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs...
K210944 · LZA
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 26, 2021
Vital Sign Monitoring Sensor (Model :XK300)
K202464 · DRT
Xandar Kardian, Inc.
Cardiovascular · 242d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
DeepHealth, Inc.
Radiology · 137d
Cleared Apr 15, 2021
SKORE (Colors & Flavors), SKORE (Colors)
K202403 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 237d
Cleared Apr 14, 2021
F&P Visairo NIV Mask Range
K203449 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 142d
Cleared Apr 09, 2021
HYPER Focus
K210418 · KPS
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Apr 02, 2021
Eclipse II with Smart Noise Cancellation
K202441 · MQB
Carestream Health, Inc.
Radiology · 219d
Cleared Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
K202228 · DXN
Omron Healthcare, Inc.
Cardiovascular · 237d
Cleared Mar 31, 2021
syngo.CT Lung CAD
K203258 · OEB
Siemens Healthcare GmbH
Radiology · 146d
Cleared Mar 29, 2021
StarGuide
K210173 · KPS
Ge Healthcare
Radiology · 66d