11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
FDA 510(k)
FDA Class 2
·Cardiovascular
FASTIN ORTHOCORD
FDA UDI
Medos International Sàrl·10886705008728·FASTIN RC w/ORTHOCORD Titanium Anchor with two ...
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·February 11, 2025
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 21, 2025
InnoClip Disposable Clip Applier, InnoClip Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTRAMEDULLARY NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TAPERLOC POR FMRL LAT 13.5X147
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 4, 2014
CONTINU-FLO SOLUTION SET 112"
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·August 19, 2011
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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