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

5,280 results for "health"
2665–2688 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 26, 2007
PSI BANDS
K070766 · MVV
Psi Health Solutions, Inc.
Neurology · 128d
Cleared Jul 17, 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · FMZ
Ge Healthcare
General Hospital · 81d
Cleared Jul 13, 2007
MEPILEX AG DRESSING
K071354 · FRO
Monlycke Health Care
General & Plastic Surgery · 59d
Cleared Jul 13, 2007
AUTOVENT 4000 WITH CPAP
K070636 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 128d
Cleared Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · MWI
Omron Healthcare, Inc.
Cardiovascular · 17d
Cleared Jun 29, 2007
MEDICK MHM200 PERSONAL HEART MONITOR
K063339 · MLO
Medick Healthcare , Ltd.
Cardiovascular · 235d
Cleared Jun 22, 2007
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
K071297 · LLZ
Agfa Healthcare Corp.
Radiology · 44d
Cleared Jun 22, 2007
TRIFLEX SELECT
K070647 · KGO
Cardinal Health, Inc.
General Hospital · 106d
Cleared Jun 21, 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
K070941 · NBW
Taidoc Technology Corporation
Chemistry · 78d
Cleared Jun 21, 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491 · FLL
K-Jump Health Co., Ltd.
General Hospital · 121d
Cleared Jun 18, 2007
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A...
K071020 · MHX
Ge Healthcare
Cardiovascular · 69d
Cleared Jun 14, 2007
LUMILOC (TM) SAFETY INTRODUCER NEEDLE
K070449 · KNT
Specialized Health Products...
Gastroenterology & Urology · 119d
Cleared Jun 07, 2007
HEALTH CHECK KIOSK
K063008 · DXN
Xperex Corporation
Cardiovascular · 248d
Cleared May 25, 2007
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · MEB
Baxter Healthcare Corp
General Hospital · 23d
Cleared May 24, 2007
TEXIUM SYRINGE
K071108 · FMF
Cardinal Health, Alaris Products
General Hospital · 35d
Cleared May 16, 2007
REPROCESSED LIGASURE VESSEL SEALER/DIVIDER
K062525 · GEI
Ascent Healthcare Solutions
General & Plastic Surgery · 261d
Cleared May 11, 2007
SKIPPI POWERED WHEELCHAIR FOR CHILDREN
K070318 · ITI
Otto Bock Healthcare LP
Physical Medicine · 98d
Cleared May 11, 2007
MODIFICATION TO FLOWSCREEN
K062011 · BTY
Viasys Healthcare GmbH
Anesthesiology · 298d
Cleared May 09, 2007
COLIN PRESS MATE, MODEL BP S510
K063690 · MHX
Omron Healthcare, Inc.
Cardiovascular · 148d
Cleared May 08, 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K071162 · MQB
Agfa Healthcare Corp.
Radiology · 12d
Not Cleared May 08, 2007
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE
DEN060009 · NZJ
3M Company
General Hospital · 217d
Cleared May 07, 2007
TOP-RANK ADHESIVE ELECTRODE
K070612 · GXY
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 63d
Cleared May 04, 2007
CORSCREEN
K070614 · DPS
Viasys Healthcare GmbH
Cardiovascular · 60d
Cleared May 03, 2007
AUTOVENT MODEL 4000
K070120 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 111d