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"
1993–2016 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 04, 2013
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING...
K123731 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 30d
Cleared Jan 04, 2013
BODY FAT SCALE MODEL SF-371
K122976 · MNW
Shenzhen Belter Health Measurement...
Gastroenterology & Urology · 100d
Cleared Jan 03, 2013
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 182d
Cleared Jan 03, 2013
DOPPLEX ABILITY
K121108 · JOM
Huntleigh Healthcare
Cardiovascular · 266d
Cleared Jan 02, 2013
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY...
K122457 · OWB
Ge Healthcare
Radiology · 142d
Cleared Dec 21, 2012
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003
K122609 · JOW
Venous Health Systems, Inc.
Cardiovascular · 116d
Cleared Dec 20, 2012
HEALTHVIEW ECG MANAGER
K123466 · DQK
Lumedx
Cardiovascular · 41d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · DFC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Dec 18, 2012
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K123564 · IYN
Ge Healthcare
Radiology · 28d
Cleared Dec 14, 2012
PERCUNAV
K121498 · JAK
Philips Health Care
Radiology · 207d
Cleared Dec 06, 2012
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA...
K121994 · CDD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 147d
Cleared Nov 28, 2012
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 163d
Cleared Nov 20, 2012
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
K123229 · DRG
Intouch Health, Inc.
Cardiovascular · 36d
Cleared Nov 20, 2012
HEALTHMATEFOREVER
K121757 · NUH
Healthmate International, LLC
Neurology · 158d
Cleared Nov 19, 2012
NON-CONTACT THERMOMETER
K120711 · FLL
K-Jump Health Co., Ltd.
General Hospital · 256d
Cleared Nov 16, 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · LLZ
Ge Healthcare
Radiology · 37d
Cleared Nov 16, 2012
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING...
K123026 · LYY
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Nov 16, 2012
PEDIATRIC POSITIONER PAD SET
K122174 · KXH
Ge Healthcare Coils (Usa Instruments,...
Radiology · 116d
Cleared Nov 07, 2012
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
K122912 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 47d
Cleared Nov 06, 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998 · LZA
Northstar Healthcare Holdings
General Hospital · 40d
Cleared Nov 02, 2012
FLIGHTPLAN FOR LIVER
K121200 · LLZ
Ge Healthcare
Radiology · 197d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Carestream Health, Inc.
Radiology · 64d
Cleared Oct 15, 2012
FINGERTIP PULSE OXIMETER
K121697 · DQA
Andon Health Co, Ltd.
Anesthesiology · 130d