16 results · 28ms · Sources: EU EUDAMED, US FDA

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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