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"
2233–2256 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 18, 2011
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7...
K100344 · MOI
Siemens Healthcare Diagnostics
Immunology · 437d
Cleared Apr 15, 2011
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K110921 · LZA
Cardinal Health, Inc.
General Hospital · 14d
Cleared Apr 12, 2011
WALDO PATIENT MONITOR
K110334 · DRG
Waldo Health
Cardiovascular · 67d
Cleared Apr 12, 2011
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI...
K100321 · LTK
Siemens Healthcare Diagnostics
Immunology · 432d
Cleared Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
K110169 · JIT
Siemens Healthcare Diagnostics
Chemistry · 77d
Cleared Apr 06, 2011
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7...
K100375 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 418d
Cleared Apr 04, 2011
DIGITAL FOREHEAD THERMOMETER
K103617 · FLL
K-Jump Health Co., Ltd.
General Hospital · 115d
Cleared Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS...
K102936 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 177d
Cleared Mar 28, 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 459d
Cleared Mar 25, 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE...
K103551 · FPA
Baxter Healthcare Corp
General Hospital · 113d
Cleared Mar 24, 2011
ZEST PETITE NASAL MASK
K103786 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 87d
Cleared Mar 23, 2011
CELSTAT
K103245 · QSY
Baxter Healthcare Corp
General & Plastic Surgery · 141d
Cleared Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
K110151 · LNH
Philips Health Care
Radiology · 63d
Cleared Mar 21, 2011
HEM-4030
K110501 · DXN
Omron Healthcare, Inc.
Cardiovascular · 27d
Cleared Mar 18, 2011
EMIT II PLUS6-ACETYLMORPHINE ASSAY
K102779 · DJG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Mar 17, 2011
WINSTIM
K102190 · IMG
Johari Digital Healthcare , Ltd.
Physical Medicine · 226d
Cleared Mar 15, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110018 · DXN
Andon Health Co, Ltd.
Cardiovascular · 71d
Cleared Mar 11, 2011
AIDA DIAGNOSTIC ULTRASOUND SYSTEM
K103148 · IYO
Panasonic Healthcare Co., Ltd.
Radiology · 137d
Cleared Mar 09, 2011
VOLUSON S6, VOLUSON S8
K103649 · IYN
Ge Healthcare
Radiology · 84d
Cleared Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
K103335 · MOS
Ge Healthcare
Radiology · 112d
Cleared Mar 07, 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · CFR
Siemens Healthcare Diagnostics
Chemistry · 249d
Cleared Mar 04, 2011
VIEWPOINT 6
K103458 · LLZ
Ge Healthcare
Radiology · 101d
Cleared Mar 03, 2011
AXIS PACS, HMS PACS
K103679 · LLZ
Axis Health Care, LLC
Radiology · 76d
Cleared Mar 03, 2011
SPACELABS MULTI-PARAMETER MODULE
K103142 · DSI
Spacelabs Healthcare, Inc.
Cardiovascular · 129d