14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G-COAT
FDA 510(k)
FDA Class 2
·Dental
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848878·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE KH...
BIOPORTA SOLDER 1020
FDA 510(k)
FDA Class 2
·Dental
THEKEN LARGE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011
INNOVA 4100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 11, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·March 16, 2011
CELL DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 22, 2008
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