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"
2449–2472 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Carestream Health, Inc.
Radiology · 88d
Cleared May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC...
K090330 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 101d
Cleared May 20, 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 97d
Cleared May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672 · MQB
Agfa Healthcare N.V.
Radiology · 66d
Cleared May 18, 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K083507 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 173d
Cleared May 18, 2009
MASTERSCREEN PAED - BABY BODY
K081823 · CCM
Viasys Healthcare GmbH
Anesthesiology · 325d
Cleared May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
K090413 · LCP
Bayer Healthcare, LLC
Chemistry · 85d
Cleared May 14, 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 178d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · JLW
Siemens Healthcare Diagnostics
Chemistry · 135d
Cleared May 06, 2009
ASTHMA MONITOR MODEL, AM1
K090486 · BZG
Cardinal Health Germany 234 GmbH
Anesthesiology · 70d
Cleared May 06, 2009
LASER TOUCHONE
K083822 · GZJ
Laser Health Technologies, LLC
Neurology · 135d
Cleared May 01, 2009
OEC 9900 ELITE
K082781 · OWB
Ge Healthcare Surgery
Radiology · 221d
Cleared May 01, 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 241d
Cleared Apr 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K090963 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d
Cleared Apr 30, 2009
GE DATEX-OHMEDA S/5 ADU CARESTATION
K090892 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared Apr 30, 2009
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
K090556 · MHX
Spacelabs Healthcare Medical...
Cardiovascular · 59d