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"
2089–2112 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 16, 2012
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 480d
Cleared Apr 13, 2012
DRX-REVOLUTION MOBILE X-RAY SYSTEM
K120062 · IZL
Carestream Health, Inc.
Radiology · 95d
Cleared Apr 13, 2012
MECHANICAL WHEELCHAIR
K120032 · IOR
Aikin Healthcare Co., Ltd.
Physical Medicine · 100d
Cleared Apr 13, 2012
CLEARVISION DR 7000F
K102327 · MQB
Jpi Healthcare Co, Ltd.
Radiology · 605d
Cleared Apr 06, 2012
OEC 9900 ELITE
K120613 · OXO
Ge Healthcare Surgery GE Oec Medical...
Radiology · 37d
Cleared Mar 30, 2012
GE ECHOPAC
K120221 · LLZ
Ge Healthcare
Radiology · 65d
Cleared Mar 30, 2012
ULTRA BEAUTY
K112351 · NFO
Johari Digital Healthcare , Ltd.
Neurology · 227d
Cleared Mar 30, 2012
RESPIRATORY HUMIDIFER
K110019 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 452d
Cleared Mar 29, 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 29d
Cleared Mar 28, 2012
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
K112950 · IOR
Jiangsu Healthy Medical Equipment Co;Ltd
Physical Medicine · 176d
Cleared Mar 28, 2012
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
K112948 · IOR
Jiangsu Healthy Way Medical Equipment...
Physical Medicine · 176d
Cleared Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894 · LFR
Bayer Healthcare
Chemistry · 364d
Cleared Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
K110587 · LFR
Bayer Healthcare, LLC
Chemistry · 393d
Cleared Mar 22, 2012
SPACELABS ARKON ANESTHESIA WORKSTATION
K113051 · CBK
Spacelabs Healthcare
Anesthesiology · 161d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
K112012 · LZA
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 21, 2012
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K112005 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 252d
Cleared Mar 16, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
K113239 · DXN
Health & Life Co., Ltd.
Cardiovascular · 135d
Cleared Mar 09, 2012
QLAB QUANTIFICATION SOFTWARE
K120525 · LLZ
Philips Healthcare Group
Radiology · 16d
Cleared Mar 06, 2012
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
K111268 · LFR
Bayer Healthcare
Chemistry · 307d
Cleared Mar 02, 2012
CS 1600 INTRAORAL CAMERA
K111423 · NBL
Carestream Health, Inc.
Dental · 284d
Cleared Mar 01, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
K113238 · DXN
Health & Life Co., Ltd.
Cardiovascular · 120d
Cleared Mar 01, 2012
OASYS SURGICAL LIGHT CONTROLLER
K112133 · FTA
Oasys Healthcare
General & Plastic Surgery · 219d
Cleared Feb 23, 2012
PILAIRO NASAL PILLOWS MASK
K120027 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 51d
Cleared Feb 17, 2012
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
K120321 · IYN
Philips Health Care
Radiology · 15d