FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
2185–2208 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Mar 02, 2011
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
K101850 · CBK
Spacelabs Healthcare, Ltd.
Anesthesiology · 244d
Cleared Feb 25, 2011
NON-CONTACT INFRARED THERMOMETER
K102947 · FLL
K-Jump Health Co., Ltd.
General Hospital · 144d
Cleared Feb 23, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
K102939 · DXN
Andon Health Co, Ltd.
Cardiovascular · 142d
Cleared Feb 18, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110330 · DXN
Andon Health Co, Ltd.
Cardiovascular · 15d
Cleared Feb 18, 2011
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
K103701 · JIX
Siemens Healthcare Diagnostics, Inc.
Immunology · 60d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 48d
Cleared Feb 08, 2011
INTEL HEALTH GUIDE
K103276 · DRG
Intel Corporation Digital Health Group
Cardiovascular · 95d