9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOMAS PIN SD 6, 8, AND 10 MM
FDA 510(k)
FDA Class 2
·Dental
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARIES DETECTOR
FDA 510(k)
FDA Class 2
·Dental
VERTE-STACK® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·October 7, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
ZENITH FLEX AAA MAIN BODY DELIVERY SYSTEM
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 17, 2008
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·April 13, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015