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"
817–840 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 2021
Eclipse PRO
K211651 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 178d
Cleared Nov 22, 2021
Philips Incisive CT on Trailer
K211168 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 217d
Cleared Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
K211662 · NLG
Innovative Health, LLC
Cardiovascular · 170d
Cleared Nov 16, 2021
Opulent TiNbN Coated Knee
K212839 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 70d
Cleared Nov 15, 2021
Clarius Ultrasound Scanner
K213436 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Nov 10, 2021
Disposable Automatic Core Biopsy Instrument
K212284 · KNW
Suzhou Leapmed Healthcare Corporation
Gastroenterology & Urology · 112d
Cleared Nov 03, 2021
Nulife
K210969 · KGO
Mrk Healthcare Pvt, Ltd.
General Hospital · 217d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
K201496 · DFH
Siemens Healthcare Diagnostics...
Immunology · 511d
Cleared Oct 29, 2021
Phoenix Digital Thermometer
K201032 · FLL
Phoenix Innovative Healthcare...
General Hospital · 557d
Cleared Oct 27, 2021
V.A.C.ULTA Negative Pressure Wound Therapy System
K203316 · OMP
Kci, A Part of 3M Health Care...
General & Plastic Surgery · 351d
Cleared Oct 25, 2021
Ultrasonic Surgical & Electrosurgical Generator
K210488 · GEI
Surgnova Healthcare Technologies...
General & Plastic Surgery · 248d
Cleared Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K211171 · CCK
GE Healthcare Finland Oy
Anesthesiology · 185d
Cleared Oct 20, 2021
iRAD
K212470 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 75d
Cleared Oct 19, 2021
U9000 Plus Ultrafilter
K211035 · FIP
Baxter Healthcare Corporation
Gastroenterology & Urology · 195d
Cleared Oct 18, 2021
Change Healthcare Cardiology
K212528 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 68d
Cleared Oct 18, 2021
Surgical Gown
K211809 · FYA
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 129d
Cleared Oct 13, 2021
Video Endoscopy System, 3D Video Endoscopy System
K210116 · HET
Surgnova Healthcare Technologies...
Obstetrics & Gynecology · 267d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 112d
Cleared Oct 07, 2021
OASIS MRI System
K211406 · LNH
Hitachi Healthcare Americas
Radiology · 154d
Cleared Oct 06, 2021
ZinRom Nitrile examination gloves
K211719 · LZA
Changzhou Xingrong Medical Technology...
General Hospital · 124d
Cleared Oct 05, 2021
Cala Trio
K203288 · QBC
Cala Health, Inc.
Neurology · 330d
Cleared Sep 30, 2021
Jada System
K212757 · OQY
Alydia Health
Obstetrics & Gynecology · 30d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d