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"
2185–2208 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 19, 2011
INFOSEND GSM
K110316 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 197d
Cleared Aug 17, 2011
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 154d
Cleared Aug 15, 2011
ION HEALTH USB INSTA-SCAN THERMOMETER
K111974 · FLL
Taidoc Technology Corporation
General Hospital · 34d
Cleared Aug 15, 2011
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · MQM
Siemens Healthcare Diagnostics
Chemistry · 196d
Cleared Aug 05, 2011
IMPAX NEXT GENERATION
K111945 · LLZ
Agfa Healthcare N.V.
Radiology · 28d
Cleared Aug 04, 2011
MICROSCAN(R) MICROSTREP PLUS(R)
K111677 · LRG
Siemens Healthcare Diagnostics, Inc.
Microbiology · 50d
Cleared Aug 03, 2011
TELEMEDCARE HEALTH MONITOR
K103796 · DRG
Telemedcare Pty, Ltd.
Cardiovascular · 219d
Cleared Aug 02, 2011
TRUSIGNAL R SPO2 PEDITIP SENSOR
K103802 · DQA
GE Healthcare Finland Oy
Anesthesiology · 217d
Cleared Aug 01, 2011
SYPHILIS HEALTH CHECK
K102400 · LIP
Diagnostics Direct, LLC
Microbiology · 342d
Cleared Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · DHB
Siemens Healthcare Diagnostics
Immunology · 423d
Cleared Jul 28, 2011
INTELLISPACE PACS 4.X
K111804 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 31d
Cleared Jul 28, 2011
MRI-Q SYSTEM
K111222 · LLZ
Resonance Health Analysis Services...
Radiology · 87d
Cleared Jul 26, 2011
LOGIQ S8
K111582 · IYN
Ge Healthcare
Radiology · 50d
Cleared Jul 26, 2011
INTEGRATED INNOVA - S5I SYSTEM OPTION
K111209 · IZI
Ge Healthcare
Radiology · 88d
Cleared Jul 22, 2011
LOGIQ E9
K110943 · IYN
Ge Healthcare
Radiology · 109d
Cleared Jul 20, 2011
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205 · LRG
Siemens Healthcare Diagnostics, Inc.
Microbiology · 82d
Cleared Jul 20, 2011
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K103745 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 209d
Cleared Jul 19, 2011
MINI TELEMETRY SYSTEM
K110556 · HGM
Wipro GE Healthcare Private, Ltd.
Obstetrics & Gynecology · 141d
Cleared Jul 19, 2011
ENTROPY EASYFIT SENSOR
K103129 · GWQ
Ge Healthcare
Neurology · 270d
Cleared Jul 18, 2011
REPROCESSED ELECTROSURGICAL INSTRUMENT
K110189 · NUJ
Ascent Healthcare Solutions
General & Plastic Surgery · 175d
Cleared Jul 15, 2011
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · IOR
Otto Bock Healthcare LP
Physical Medicine · 91d
Cleared Jul 15, 2011
BODY ANALYSIS SCALE, MODEL BG 17
K110928 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 102d
Cleared Jul 15, 2011
ACG-8511 PORTABLE ECG MONITOR
K110328 · DPS
Andon Health Co, Ltd.
Cardiovascular · 162d
Cleared Jul 08, 2011
RHA2020
K111531 · HLI
Annidis Health Systems Corp.
Ophthalmic · 36d