17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code JDS·February 13, 2017
SNAP MODEL 6
FDA 510(k)
FDA Class 2
·Anesthesiology
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 2, 2026
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·June 11, 2024
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 29, 2013
SYSTEM 6 PRECISION HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·April 26, 2011
SPACEMAKER BLUNT TIP TROCAR 12MM
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·July 25, 2008
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·July 3, 2024
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 5, 2016
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·May 9, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
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