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"
841–864 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 27, 2021
Volpara Imaging Software
K211279 · LLZ
Volpara Health Technologies Limited
Radiology · 91d
Cleared Jul 24, 2021
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
K211262 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 89d
Cleared Jul 23, 2021
Disposable IV catheter
K202060 · FOZ
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 361d
Cleared Jul 21, 2021
Single-Use Surgical Mask Model FE2311B
K210970 · FXX
Byd Precison Manufacturer Co., Ltd.
General Hospital · 112d
Cleared Jul 20, 2021
Vital Signs
K211906 · QME
Oxehealth Limited
Cardiovascular · 29d
Cleared Jul 20, 2021
Change Healthcare Anatomical AI
K210719 · QIH
Change Healthcare Canada Company
Radiology · 132d
Cleared Jul 16, 2021
Velguard Surgical Face Mask
K210761 · FXX
Esstee Exports Health Care Division
General Hospital · 123d
Cleared Jul 16, 2021
ADVIA Centaur® Digoxin assay
K193397 · KXT
Siemens Healthcare Diagnostics, Inc.
Toxicology · 588d
Cleared Jul 14, 2021
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
K202304 · PZM
Nyu Langone Medical Center
Pathology · 334d
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