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"
889–912 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
K193047 · DFH
Siemens Healthcare Diagnostics...
Immunology · 621d
Cleared Jul 13, 2021
Finetest Lite Blood Glucose Monitoring System
K203562 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 218d
Cleared Jul 13, 2021
ADVIA Centaur® Total hCG assay
K200210 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 532d
Cleared Jul 09, 2021
Monarch Platform
K211493 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 09, 2021
Grosz Play Feel
K211088 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 88d
Cleared Jul 08, 2021
Medical surgical mask
K210380 · FXX
Shantou T&K Medical Equipment Factory...
General Hospital · 149d
Cleared Jul 02, 2021
SyntrFuge System
K203800 · MUU
Syntr Health Technologies, Inc.
General & Plastic Surgery · 186d
Cleared Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
K200256 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 515d
Cleared Jul 01, 2021
Avance Solo Negative Pressure Wound Therapy (NPWT) System
K203369 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 227d
Cleared Jun 25, 2021
Apache Ultrasound System
K211232 · IYN
Aco Healthcare Co., Ltd.
Radiology · 63d
Cleared Jun 22, 2021
SenoBright HD
K211215 · MUE
Ge Healthcare
Radiology · 60d
Cleared Jun 22, 2021
Disposable Surgical Mask
K210840 · FXX
Safeway Industry Healthcare.
General Hospital · 92d
Cleared Jun 18, 2021
Intravascular Extension Set
K210430 · FPA
Baxter Healthcare Corporation
General Hospital · 126d
Cleared Jun 17, 2021
Precise Position
K203514 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 199d
Cleared Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with...
K210401 · LZA
Ansell Healthcare Products, LLC
General Hospital · 123d
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