36 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1.5 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055615·
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
FDA 510(k)
FDA Class 2
·Radiology
DEPUY PINNACLE ALTRX ACETABULAR LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·March 9, 2015
LACTOSORB 1.5MM X SHAPE EXT PLATE
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code MAI·January 21, 2009
LACTOSORB 1.5MM 4 HOLE STRAIGHT PLATE
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code MAI·January 21, 2009
CONCERTO
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 7, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 28, 2011
STRATA SHUNT II
FDA Adverse Event
Injury
·MEDTRONIC NEUROLOGICAL·Product code JXG·September 5, 2008
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·March 19, 2008
BATTERY POWERDRIVER P2
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GEY·September 28, 2021
PLATE 4 HOLE WITH GAP 2.0MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·September 28, 2021
BATTERY POWERDRIVER P2
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GEY·September 28, 2021
BATTERY POWERDRIVER P2
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GEY·September 28, 2021
STER TRC 2 XD TF 1.5X4.0MM SCR
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·September 28, 2021
BATTERY POWERDRIVER P2
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GEY·September 28, 2021
BATTERY POWERDRIVER P2
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GEY·September 28, 2021
LACTO SCR 1.5X5MM 1.5 SYS 2PK
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·September 28, 2021