11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608488·BERCHTOLD 4" SOFTCARE
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 11, 2024
CEMEX SYSTEM GUN APPLICATION VERSION
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES STERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 10, 2023
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NLM·April 24, 2013
STELLARIS OPTIMIZED STABILITY VACUUM PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQC·April 13, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·July 23, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024