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"
2353–2376 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · JIL
Siemens Healthcare Diagnostics
Chemistry · 165d
Cleared Oct 08, 2009
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · LIH
Well-Life Healthcare Limited
Neurology · 29d
Cleared Sep 30, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
K092161 · DXN
Health & Life Co., Ltd.
Cardiovascular · 76d
Cleared Sep 23, 2009
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING...
K092680 · MHX
GE Healthcare Finland Oy
Cardiovascular · 22d
Cleared Sep 21, 2009
MICRO-TOUCH NITRA FREE
K092327 · LZA
Ansell Healthcare Products, LLC
General Hospital · 48d
Cleared Sep 21, 2009
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008,...
K091853 · BZK
Nspire Health, Inc.
Anesthesiology · 90d
Cleared Sep 21, 2009
HEALTHANYWHERE SYSTEM
K091220 · DRG
Healthanywhere, an Igeacare System...
Cardiovascular · 147d
Cleared Sep 15, 2009
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K092304 · KGO
Cardinal Health, Inc.
General Hospital · 48d
Cleared Sep 03, 2009
SPIROPRO
K092324 · DQA
Viasys Healthcare GmbH
Anesthesiology · 30d
Cleared Sep 01, 2009
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676 · FLL
Omron Healthcare, Inc.
General Hospital · 84d
Cleared Aug 26, 2009
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS
K091820 · NBW
Bayer Healthcare
Chemistry · 69d
Cleared Aug 25, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ,...
K092004 · OWB
Ge Healthcare
Radiology · 54d
Cleared Aug 21, 2009
CLEAN PEAK FLOW METER
K091412 · BZH
Viasys Healthcare GmbH
Anesthesiology · 100d
Cleared Aug 18, 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
K091739 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
K091738 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915,...
K091737 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
K091186 · EIA
Carestream Health, Inc.
Dental · 117d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · JJX
Siemens Healthcare Diagnostics
Chemistry · 119d
Cleared Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · MQB
Agfa Healthcare N.V.
Radiology · 19d
Cleared Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X...
K090002 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 217d
Cleared Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K091289 · DHB
Siemens Healthcare Diagnostics
Immunology · 97d
Cleared Jul 31, 2009
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K091500 · DXN
Andon Health Co, Ltd.
Cardiovascular · 71d
Cleared Jul 30, 2009
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025
K092086 · SEJ
Amerx Health Care Corp.
General & Plastic Surgery · 21d
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
K092045 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d