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"
2137–2160 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jul 08, 2011
PAINFUSOR CATHETER
K111031 · BSO
Plan 1 Health, S.R.L.
Anesthesiology · 85d
Cleared Jul 07, 2011
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH...
K103714 · KGO
Ansell Healthcare Products, LLC
General Hospital · 198d
Cleared Jul 01, 2011
WELL-LIFE OTC EMS SYSTEM
K102786 · NGX
Well-Life Healthcare Limited
Physical Medicine · 277d
Cleared Jun 24, 2011
IMPAX VOLUME VIEWING
K111638 · LLZ
Agfa Healthcare N.V.
Radiology · 11d
Cleared Jun 22, 2011
MICROSCAN MICROSTEP
K111394 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 35d
Cleared Jun 14, 2011
ADDITIVE CAP
K111217 · KPE
Baxter Healthcare Corp
General Hospital · 43d
Cleared Jun 14, 2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
K110001 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 162d