106 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304495227·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613106447·Gruber Speculum, Oval, Infant, 3.5mm x 4.5mm, O...
THE HELENA V8 IMMUNODISPLACEMENT KIT
FDA 510(k)
FDA Class 2
·Immunology
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
FDA 510(k)
FDA Class 2
·Neurology
M.U.S.T. MINI POLYAXIAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·August 27, 2025
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·April 6, 2018
MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·March 8, 2022
MUST MINI ROD TI 3.5 X 80MM (STERILE)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 13, 2021
MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·July 14, 2020
UNKNOWN DEPUY GRIPTON CUP
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 3, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 1, 2011
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/HUNTINGTON·Product code MJP·August 22, 2008
VANGUARD COMPLETE KNEE SYSTEM - CR POR FEM-RT 60
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 29, 2017
VANGUARD COMPLETE KNEE SYSTEM - TIB BRG 63/67X12
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 29, 2017
REGENEREX TIBIAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·June 29, 2017
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016
VANGUARD COMPLETE KNEE SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 13, 2017
REGENEREX TIBIAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·July 13, 2017
MICROPLASTY TIBIAL TRAYS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 13, 2017