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"
2425–2448 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jul 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
K091997 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Jul 24, 2009
JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000
K090007 · CAW
Danyang Jumao Healthcare Equipment...
Anesthesiology · 203d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · LTT
Siemens Healthcare Diagnostics
Microbiology · 83d
Cleared Jul 22, 2009
ALATECH POWDER FREE LATEX EXAMINATION GLOVE
K083761 · LYY
Alatech Healthcare, LLC
General Hospital · 216d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · KPR
Carestream Health, Inc.
Radiology · 26d
Cleared Jul 15, 2009
SONICAID FM820 AND FM830 ENCORE
K090285 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 160d
Cleared Jul 09, 2009
EASY.TOUCH INSULIN SYRINGE
K091474 · FMF
Masters Healthcare, LLC
General Hospital · 52d
Cleared Jul 09, 2009
ALARIS PC UNIT, MODELS 8000 AND 8015
K091308 · FRN
Cardinal Health 303,Inc.
General Hospital · 66d
Cleared Jul 01, 2009
INFLATABLE BONE TAMP
K090211 · NDN
Cardinal Health, Inc.
Orthopedic · 154d
Cleared Jul 01, 2009
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
K081923 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 359d
Cleared Jun 29, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA...
K091658 · OWB
Ge Healthcare
Radiology · 20d
Cleared Jun 26, 2009
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
K083256 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 234d
Cleared Jun 19, 2009
SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500,...
K083753 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 184d
Cleared Jun 10, 2009
COR12+
K091505 · DSH
Viasys Healthcare GmbH
Cardiovascular · 20d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909
K090772 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962
K090771 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d