15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESMED S8 PIONEER CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403041209·12mm x 90mm Portal Tube
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0142090·Trial, TLIF, 32L OB CRV 7Deg, 9mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112090·Tap, Cannulated, 7.5 mm
K-WIRE GAMMA Ø3,2X450 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 20, 2016
K-WIRE GAMMA Ø3,2X450 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 20, 2016
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
FDA 510(k)
FDA Class 2
·Radiology
MANAN SPRITACRE SPINAL NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR, LLC·Product code OBR·May 1, 2014
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 8, 2013
RELIANT STENT GRAFT BALLOON CATHETER - US
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DQY·March 30, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2008
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018