17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111369179·SKL-MAGNATONE STETH NON-CHILL
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C1MA011010·The Millennia software system is indicated for:...
FUTURA TOPCAP NON GAMMA-2
FDA 510(k)
FDA Class 2
·Dental
STEATHSTATION TREATMENT GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 30, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·June 13, 2008
CROSSCATH SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 6, 2019
CROSSCATH SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·February 26, 2019
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·October 29, 2012
CROSSCATH SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·June 20, 2019
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·October 29, 2012
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·October 29, 2012
COOK CELECT FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·January 3, 2017
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