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

5,282 results for "health"
2689–2712 of 5,282
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 02, 2007
COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
K070446 · GEI
Valleylab,A Division of Tyco...
General & Plastic Surgery · 76d
Cleared Apr 18, 2007
COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
K070091 · KNW
Cardinal Health, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 17, 2007
HEALTH MASK
K070467 · OBN
Polar Wrap, LLC
Anesthesiology · 60d
Cleared Apr 16, 2007
COLLEAGUE GUARDIAN CONFIGURATION TOOL
K070125 · FRN
Baxter Healthcare Corp
General Hospital · 90d
Cleared Apr 11, 2007
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL...
K070782 · MSH
Survivair Respirators, LLC
General Hospital · 21d
Cleared Mar 29, 2007
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K063076 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 174d
Cleared Mar 28, 2007
MODIFICATION TO HEALTH BUDDY APPLIANCE
K070543 · DRG
Health Hero Network, Inc.
Cardiovascular · 30d
Cleared Mar 23, 2007
PET VCAR
K063324 · JAK
Ge Healthcare
Radiology · 140d
Cleared Mar 21, 2007
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · FXX
Modern Healthcare Corp.
General Hospital · 169d
Cleared Mar 20, 2007
SUNPOLAR HEALTHLINE, MODEL 100
K062873 · DWL
E.C.I. USA Corporation
General Hospital · 176d
Cleared Mar 19, 2007
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
K070420 · ODD
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 16, 2007
VIDAR VISION 2000
K070563 · MQB
Vidar Systems Corp.
Radiology · 17d
Cleared Mar 13, 2007
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
K070421 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Mar 06, 2007
FORCETRIAD ELECTROSURGICAL GENERATOR
K070162 · GEI
Valleylab,A Division of Tyco...
General & Plastic Surgery · 48d
Cleared Mar 02, 2007
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
K070139 · MSH
Survivair, Inc.
General Hospital · 45d
Cleared Mar 01, 2007
MAXHEALTH MECHANICAL WHEELCHAIR, K1
K070176 · IOR
Maxhealth Corp.
Physical Medicine · 42d
Cleared Feb 27, 2007
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
K063696 · FRN
Baxterhealthcare, Inc.
General Hospital · 76d
Cleared Feb 23, 2007
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
K070268 · FRN
Cardinal Health 303,Inc.
General Hospital · 25d
Cleared Feb 23, 2007
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
K063023 · MSH
3M Company
General Hospital · 144d
Cleared Feb 23, 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · CAF
Omron Healthcare, Inc.
Anesthesiology · 203d
Cleared Feb 21, 2007
C300 SERIES AIR NEBULIZER COMPRESSOR
K062952 · CAF
Choice Smart Health Care Co. , Ltd.
Anesthesiology · 145d
Cleared Feb 13, 2007
BODIHEALTH SYSTEM
K052836 · GZJ
Usa Laser Therapeutics, Inc.
Neurology · 495d
Cleared Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660 · NUH
Well-Life Healthcare Limited
Neurology · 61d
Cleared Feb 01, 2007
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL...
K063855 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 35d