36 results · 27ms · Sources: EU EUDAMED, 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