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"
2377–2400 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911,...
K092588 · DXN
Andon Health Co, Ltd.
Cardiovascular · 127d
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
K093452 · DXN
Andon Health Co, Ltd.
Cardiovascular · 48d
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905,...
K092510 · DXN
Andon Health Co, Ltd.
Cardiovascular · 128d
Cleared Dec 18, 2009
SMART TENS, MODEL: D-BC05T
K091045 · GZJ
Body Clock Health Care, Ltd.
Neurology · 249d
Cleared Dec 17, 2009
HEALTHEPOD
K083174 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 416d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · LIP
Siemens Healthcare Diagnostics
Microbiology · 222d
Cleared Dec 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
K093528 · DXN
Andon Health Co, Ltd.
Cardiovascular · 18d
Cleared Dec 04, 2009
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
K092514 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 109d
Cleared Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
K090628 · NBW
Bayer Healthcare, LLC
Chemistry · 270d
Cleared Dec 03, 2009
SILS PORT MODEL SILSPT15
K093372 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 35d
Cleared Nov 30, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093277 · LYZ
Tangshan Green Healthcare Co., Ltd.
General Hospital · 42d
Cleared Nov 30, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093272 · LYZ
Tangshan Huamei Healthcare Co., Ltd.
General Hospital · 42d
Cleared Nov 27, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962,...
K093387 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Nov 25, 2009
3.0T 16 CHANNEL HEAD NECK SPINE COIL
K093348 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 29d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 18, 2009
STERILE WATER FOR INHALATION FLEX BAG, USP
K090915 · BTT
Cardinal Health, Inc.
Anesthesiology · 231d
Cleared Nov 17, 2009
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
K093389 · DXN
Computerized Screening, Inc.
Cardiovascular · 18d
Cleared Nov 17, 2009
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
K092271 · IYN
Ge Healthcare
Radiology · 112d
Cleared Nov 16, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
K092163 · DXN
Health & Life Co., Ltd.
Cardiovascular · 123d
Cleared Nov 12, 2009
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
K093410 · GDW
Surgical Devices, A Divsion of Tyco...
General & Plastic Surgery · 10d
Cleared Nov 12, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K093408 · GAM
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 10d
Cleared Nov 10, 2009
BESMED JET NEBULIZER BOTTLE SET
K091272 · CAF
Besmed Health Business Corp
Anesthesiology · 194d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669 · MQB
Agfa Healthcare N.V.
Radiology · 67d
Cleared Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914 · JJX
Bionostics, Inc.
Chemistry · 129d