18 results
·
29ms
·
Sources: EU EUDAMED, US FDA
BIPLANE TRANSRECTAL PROBE
FDA 510(k)
FDA Class 2
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450722305·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140060·Locking Cap, Temporary, Screw to Screw Distractor
Invictus® Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
AVD INTIMAX (TM) BILIARY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 14, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·December 3, 2010
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 3, 2014
INVICTUS
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·November 21, 2024
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015