9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
FDA 510(k)
FDA Class 2
·Orthopedic
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ablamap Software
FDA 510(k)
FDA Class 2
·Cardiovascular
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·May 8, 2019
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 2, 2011
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·July 9, 2013
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025