24 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOPORE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925016828·RICHARDS PISTON 4.5MM LENGTH .4MM DIAMETER PLAT...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221038135·Unitek(TM) Bicuspid Band General Purpose Wide L...
TALOS®-A
FDA UDI
SpineArt SA·07640375237743·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D26 ...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321418160·
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
FDA 510(k)
FDA Class 2
·Cardiovascular
STN PROBE
FDA 510(k)
FDA Class 2
·Radiology
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025
STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021
STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025
CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
M-VIZION PROXIMAL BODY HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026
STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021
M-VIZION INSERTER ROD
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024