10 results · 44ms · Sources: EU EUDAMED, US FDA

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RADIANCE

FDA 510(k)
FDA Class 2 ·Dental

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014607269·SKYTRON 3501B 3" SOFTCARE

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 23, 2024

RHIGENE MESACUP2 TEST- SSA

FDA 510(k)
FDA Class 2 ·Immunology

ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL

FDA 510(k)
FDA Class 2 ·Physical Medicine

VERSAFITCUP CC TRIO ACETABULAR SHELL 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 2011

SYNERGY

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·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