8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rejoni Intrauterine Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
FDA 510(k)
FDA Class 2
·Orthopedic
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Injury
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·November 4, 2014
UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 25, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025