16 results
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28ms
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Sources: EU EUDAMED, US FDA
DISTRAX
FDA 510(k)
FDA Class 2
·Dental
iTotal® PS Tibial Tray Impactor Tip
FDA UDI
Conformis, Inc.·00850268007217·iTotal® PS Tibial Tray Impactor Tip Reusable In...
Clamp, Hysterectomy, model Z 35.5cm strongly curved
FDA UDI
Geister Medizintechnik GmbH·04057034373316·Clamp, Hysterectomy, model Z
35.5cm...
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 2, 2026
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
FDA 510(k)
FDA Class 2
·Neurology
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
23 G X .75 IN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 16, 2016
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 30, 2023
SWITCH-BLADE SCISSOR REUSE HDLE 5MM 45CM
FDA Adverse Event
Injury
·CAREFUSION·Product code GEI·April 26, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 22, 2008
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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