23 results · 20ms · Sources: EU EUDAMED, US FDA

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MINIFIX BALL MINIFIX ONE

FDA 510(k)
FDA Class 2 ·Dental

ArgenZ HT+ 98x18 OM2

FDA UDI
ARGEN CORPORATION, THE·D818122052·Dental porcelain/ceramic restoration kit

Malibu™

FDA UDI
Seaspine Orthopedics Corporation·10889981029661·CONTOURED CROSSBAR, MEDIUM, 5.5 ROD

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973134·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970461·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970454·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973615·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973608·

Logical PX-Series

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000387·

CAREFUSION NICOLET EDX

FDA 510(k)
FDA Class 2 ·Neurology

40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

THERMAL SENSORY ANALYZER (TSA-II)

FDA Adverse Event
Injury ·MEDOC LTD., ADVANCED MEDICAL SURGERY MEDISCENSE USA·Product code LQW·December 26, 2019

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 21, 2013

ENTRUST VR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011

MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KNW·August 14, 2008

CONTOURED CROSSBAR MEDIUM 5.5 ROD

FDA Adverse Event
Other ·SEASPINE, INC.·Product code NKB·August 28, 2014

QSENSE CPM THERMAL SENSORY ANALYZER 2001

FDA Adverse Event
Malfunction ·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022

REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

FDA Enforcement
Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

SOMATOM Edge Plus-Computed tomography system Model 1026700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021