16 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PMMA Blocks for Dental Use
FDA 510(k)
FDA Class 2
·Dental
VIA MICROCATHETER, VIA PLUS MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOLOY
FDA 510(k)
FDA Class 2
·Dental
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·August 18, 2017
UNK - NAILS
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·March 31, 2020
11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·March 31, 2020
AIM-ARM 125 F/PFNA BLADE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·March 31, 2020
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 25, 2011
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 9, 2013
4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·March 31, 2020
. 5.0MM TROCAR 210MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·March 31, 2020
INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·August 18, 2017
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
FDA Enforcement
Class II
·Terminated·Acumed LLC·May 7, 2014
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026