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"
2065–2088 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 11, 2012
BLEASE700/900 SERIES VENTILATORS
K112729 · CBK
Spacelabs Healthcare
Anesthesiology · 265d
Cleared Jun 06, 2012
ARIATELE TELEMETRY TRANSMITTER (96281)
K121480 · MHX
Spacelabs Healthcare
Cardiovascular · 19d
Cleared Jun 05, 2012
CENTRICITY PACS-IW
K121387 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 28d
Cleared Jun 01, 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · DXN
Andon Health Co, Ltd.
Cardiovascular · 88d
Cleared Jun 01, 2012
CARDINAL HEALTH DURABLUE STERILIZATION WRAP
K120542 · FRG
Cardinal Health-Medical Products and...
General Hospital · 99d
Cleared May 30, 2012
3M SPOTON TEMPERATURE MONITORING SYSTEM
K120412 · FLL
Arizant Healthcare, Inc.
General Hospital · 110d
Cleared May 30, 2012
SOLOHEALTH STATION
K113402 · DXN
Solohealth, Inc.
Cardiovascular · 195d
Cleared May 25, 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD...
K110074 · NBW
Health & Life Co., Ltd.
Chemistry · 501d
Cleared May 24, 2012
REMOTE PRESENCE SYSTEM
K120895 · DRG
Intouch Health, Inc.
Cardiovascular · 62d
Cleared May 23, 2012
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN...
K120934 · KGO
Cardinal Health, Inc.
General Hospital · 56d
Cleared May 23, 2012
PUSH-ON NEEDLE 30GX8MM
K120191 · FMI
Scandinavian Health Limited
General Hospital · 121d
Cleared May 22, 2012
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED...
K120443 · FPA
Baxter Healthcare Corporation - Renal...
General Hospital · 98d
Cleared May 18, 2012
ORION II CT CVC
K113622 · FOZ
Health Line International Corporation...
General Hospital · 162d
Cleared May 17, 2012
LONG LIFE PADTM
K120516 · GXY
Omron Healthcare, Inc.
Neurology · 86d
Cleared May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · CFR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 70d
Cleared May 14, 2012
COMED K-SERIES MANUAL WHEELCHAIR
K120077 · IOR
Danyang Comed Healthcare Co., Ltd.
Physical Medicine · 125d
Cleared May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared May 08, 2012
MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
K113577 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 155d
Cleared May 04, 2012
HLIC NEEDLE-LESS VALVE
K120548 · FPA
Health Line International Corporation
General Hospital · 71d
Cleared May 03, 2012
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · KHP
Siemens Healthcare Diagnostics
Chemistry · 184d
Cleared May 02, 2012
LULLABY LED PHOTTHERAPY SYSTEM
K120168 · LBI
Wipro GE Healthcare Private, Ltd.
General Hospital · 104d
Cleared Apr 27, 2012
VOLUSON S6, VOLUSON S8
K120741 · IYN
Ge Healthcare
Radiology · 46d
Cleared Apr 27, 2012
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K113707 · KGO
Cardinal Health-Medical Products and...
General Hospital · 133d
Cleared Apr 19, 2012
OPTIMA NM/CT 640
K121019 · KPS
Ge Healthcare
Radiology · 15d