17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3880 MRI Patient Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277119773·Femur/Tibia Fracture Distractor Frame
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189003001·IN-OVATION® R Pickard RX Adolescent KIT
Origin Lateral Offset Collared Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215017750·
Origin Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051747·
Paxeon Origin
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570204977·
ANTI-HAV
FDA 510(k)
FDA Class 2
·Microbiology
ZOLL E SERIES WITH INTIBATION ASSIST OPTION
FDA 510(k)
FDA Class 3
·Cardiovascular
STRATUS Stem - High Offset - Collared - Size 9
FDA UDI
AMPLITUDE SAS·03701089504898·
DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM
FDA Adverse Event
Malfunction
·IN2BONES SAS·Product code HTW·September 19, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 22, 2011
NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·WORLD HEART, INC.·Product code DSQ·September 23, 2008
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020