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"
2377–2400 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905
K090770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
K090769 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,
K090768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · DKB
Siemens Healthcare Diagnostics
Toxicology · 61d
Cleared May 29, 2009
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · QJQ
Johari Digital Healthcare , Ltd.
Neurology · 142d
Cleared May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · JBQ
Siemens Healthcare Diagnostics
Hematology · 339d
Cleared May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K090257 · DHB
Siemens Healthcare Diagnostics
Immunology · 113d
Cleared May 22, 2009
DIAGNOSTIC CATHETER SYSTEM
K091250 · EOQ
Cardinal Health, Inc.
Ear, Nose, Throat · 24d