19 results
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19ms
·
Sources: EU EUDAMED, US FDA
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
FDA 510(k)
FDA Class 2
·Immunology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034013·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252034013·ANODYNE CERVICAL SCREW - FIXED SELF DRILLING -...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0360130·Modular Tip, Bifid, Offset Right
Liberty Anterior Cervical Plate
FDA UDI
VALORUS SPINE LLC·00811771030536·Fixed Screw, Self Drilling, 4.0x13mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820340130·Zadik Calcaneal Guide, 34mm x 13mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620340130·Quad Channel Met-Traverse, 34mm x 13mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710450340130·Medial Guide, Closing Wedge Osteotomy, 34mm x 13mm
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014
TRANSDUCER, S8 3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014
TRANSDUCER S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 30, 2011
HOMER MAMMALOK GOLD ANGIOTECH
FDA Adverse Event
Injury
·MEDICAL DEVICE TECHNOLOGIES·Product code MIJ·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