25 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OEC 9900 ELITE
FDA 510(k)
FDA Class 2
·Radiology
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564030887·4 SHEET PACK
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800597·Sheet, 4-Pack
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129868·PS Insert, Size 6 x 13mm
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551045830·TRACTION BAIL WITH HEADBLOCK ATTACHMENT HARDWARE
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477740·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383555616·Gutta Percha Points is used to root canal filin...
Zavation
FDA UDI
Zavation LLC·00842166188174·Custom PLIF SIZER
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018159·Wide Jaw Punch medium 15 degree up milled 3.5mm...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857551329·Offset Blade Left Size 70 mm
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BIOMED WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
SENSAR ACRYLIC IOL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·June 10, 2011
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012