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"
2713–2736 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 31, 2007
REPROCESSED TROCARS
K062497 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 159d
Cleared Jan 29, 2007
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
K063536 · GAM
Tyco Healthcare Group
General & Plastic Surgery · 68d
Cleared Jan 25, 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · FRO
Molnlycke Health Care
General & Plastic Surgery · 234d
Cleared Jan 25, 2007
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · FRN
Baxter Healthcare Corp
General Hospital · 458d
Cleared Jan 12, 2007
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS...
K063747 · MSH
Inovel, LLC
General Hospital · 24d
Cleared Jan 08, 2007
POWERTONE, MODEL PT-11
K062439 · NGX
Johari Digital Healthcare , Ltd.
Physical Medicine · 140d
Cleared Dec 29, 2006
MODIFICATION TO HEALTH BUDDY APPLIANCE
K063612 · DRG
Health Hero Network, Inc.
Cardiovascular · 25d
Cleared Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276 · JIL
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Dec 26, 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 20d
Cleared Dec 22, 2006
OPUS HC482 DIRECT NASAL MASK
K063036 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 80d
Cleared Dec 20, 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 77d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Dec 07, 2006
PRN THERMALCARE, MODEL 3000
K062794 · DWJ
American Healthcare Products, Inc.
Cardiovascular · 80d
Cleared Dec 06, 2006
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV,...
K062324 · MHX
Ge Healthcare
Cardiovascular · 119d
Cleared Nov 30, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688 · LYY
Ug Healthcare (Usa), Inc.
General Hospital · 83d
Cleared Nov 28, 2006
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
K063288 · FRN
Cardinal Health 303,Inc.
General Hospital · 27d
Cleared Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
K062347 · NBW
Bayer Healthcare, LLC
Chemistry · 104d
Cleared Nov 21, 2006
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
K063291 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 20d
Cleared Nov 07, 2006
XERON PACS
K062757 · LLZ
Xeron Healthcare Corp.
Radiology · 54d
Cleared Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 111d
Cleared Nov 03, 2006
SONARA
K060421 · IYN
Viasys Healthcare, Inc.
Radiology · 259d
Cleared Nov 02, 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 177d
Cleared Oct 27, 2006
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
K062016 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 102d
Cleared Oct 24, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062665 · MSH
Inovel, LLC
General Hospital · 47d