17 results
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49ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
FDA 510(k)
FDA Class 2
·Radiology
Non-Locking Screw, 2.7mm x 14mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026290·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008617·3.0mm x 14mm Lag Screw
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450270134·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035217·3.0 x 14mm Lag Screw, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694067461·3.0 x 14mm Lag Screw Sterile Qty 5
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOMATOM EMOTION MS
FDA 510(k)
FDA Class 2
·Radiology
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PROMUS ELEMENT ?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 29, 2013
HAKIM INLINE PROGRAMMABLE VALVE SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 4, 2011
RESTORE ULTRA
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·July 28, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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