10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033816·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
CANON FULL AUTO TONOMETER TX-F
FDA 510(k)
FDA Class 2
·Ophthalmic
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
FDA 510(k)
FDA Class 2
·Orthopedic
SCREWDRIVER BLADE, T7, AO
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code LXH·April 3, 2013
PINNACLE SECTOR II CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 17, 2011
NEUROFORM MICRODELIVERY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - NEUROVASCULAR DIVISION·Product code NJE·April 24, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024