19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REFLECTION CONSTRAINED LINER
FDA 510(k)
FDA Class 2
·Orthopedic
REFLECTION CONSTRAINED ACETABULAR LINER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025
Woven Filiform Straight Tip
FDA UDI
C. R. Bard, Inc.·00801741073021·Woven Filiform Straight Tip
Ortho Shop
FDA UDI
Orthoshop, LLC·00810152071588·0.018 Copper NiTi Wire with Stops Damon Form Un...
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
ACCELERATOR RECIPROCATING CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M-H HA/PC 11X160MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
M-H SOLID SHELL HA/PC DIA54MM LN24
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·March 1, 2016
AUTO ENDO5 ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·August 8, 2017
MALLORY-HEAD SHORT FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·July 28, 2017
MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·August 11, 2016
BI-METRIC/X POR NC STEM 12X140
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·March 26, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2011
ISOLETTE
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL·Product code FMZ·March 20, 2008
MLRY-HD XR LAT POR FMRL 8MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·July 4, 2018
M-H HA/PC 12X165MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014