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"
865–888 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 26, 2021
Visby Medical Sexual Health
K200748 · QEP
Visby Medical
Microbiology · 521d
Cleared Aug 25, 2021
Diagnostic X-ray System/PLX5200A
K212134 · IZL
Nanjing Perlove Medical Equipment...
Radiology · 48d
Cleared Aug 24, 2021
SKR 3000
K210619 · MQB
Konica Minolta, Inc.
Radiology · 176d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · QQB
Siemens Healthcare Diagnostics, Inc.
Chemistry · 603d
Cleared Aug 17, 2021
Disposable Medical Nitrile Gloves
K211708 · LZA
Jiangsu Health-Peace Medical...
General Hospital · 75d
Cleared Aug 16, 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · LZA
Rhino Health, Inc.
General Hospital · 286d
Cleared Aug 13, 2021
Insignis Subcutaneous Needle Sets
K202279 · FPA
Innovative Health Sciences, LLC
General Hospital · 367d
Cleared Aug 11, 2021
Medical Face Mask
K211353 · FXX
Shenzhen Lyttop Healthcare Limited
General Hospital · 100d
Cleared Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
K203448 · JAK
Shanghai United Imaging Healthcare...
Radiology · 261d
Cleared Aug 06, 2021
Senographe Pristina
K211725 · MUE
Ge Healthcare
Radiology · 63d
Cleared Aug 04, 2021
PrevisEA Device
K211068 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 137d
Cleared Jul 29, 2021
Hemafuse System
K210862 · CAC
Sisu Global Health
Cardiovascular · 128d
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 136d
Cleared Jul 29, 2021
FiteBac CC OrthoSeal
K210115 · DYH
Largent Health, LLC
Dental · 191d
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