37 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stryker Consolidated Operating Room Equipment (CORE) 2 Console
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741718400·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674171840060·
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657019248·Ring curette 3mm diameter of sharp cutting ring
Sklar®
FDA UDI
SKLAR CORPORATION·10649111225291·MOYNIHAN ARTERY FCP STR 5 3/4"
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100790·FLIERINGA FIXATION RING 18MM
Lacrimal Chisel
FDA UDI
KATENA PRODUCTS, INC.·00841668108581·WEST LACRIMAL CHISEL STRAIGHT
EMERGE FRACTIONAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·March 30, 2026
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 24, 2026
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
OPTIPAC 80 REFOB PLUS BONE CMT-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·March 17, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
6000 CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 23, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBB·March 12, 2026
REFOBACIN BONE CEMENT R 2X20-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 11, 2026
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 21, 2018