10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE CANNULATED CORTICAL BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083017071·STR, 4 electrode, MPD-CS-L, 5mm electrode spacing
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515230101·Harrison Knife, very sm bld ang 45deg, 6 1/8"
GPC Intraheal Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
CRYOCARE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO·Product code BTR·January 2, 2013
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA·Product code DQX·November 20, 2010
Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
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