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"
2401–2424 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 30, 2009
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
K093300 · KGO
Cardinal Health, Inc.
General Hospital · 9d
Cleared Oct 30, 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · LHI
Baxter Healthcare Corporation
General Hospital · 87d
Cleared Oct 30, 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX...
K083133 · FRO
Andover Healthcare, Inc.
General & Plastic Surgery · 372d
Cleared Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
K091916 · DAP
Siemens Healthcare Diagnostics
Hematology · 121d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · LON
Siemens Healthcare Diagnostics
Microbiology · 30d
Cleared Oct 21, 2009
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
K092425 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 75d
Cleared Oct 21, 2009
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE,...
K092283 · DFZ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Oct 09, 2009
AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
K092806 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 28d
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