19 results · 19ms · Sources: EU EUDAMED, US FDA

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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