17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780804·LEVAMED ACTIVE ANKLE SUP SLVR R II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
FDA 510(k)
FDA Class 2
·Dental
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
FDA 510(k)
FDA Class 2
·Radiology
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
LIFESTENT VALEO VASCULAR STENT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·August 9, 2010
VALEO VASCULAR STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010
ALIGNTM TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·March 13, 2013
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 9, 2011
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 8, 2013
UNKNOWN HIP ACETABULAR POLY/METAL HEMI
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 17, 2019
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·October 31, 2014
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012