16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
FDA 510(k)
FDA Class 2
·Orthopedic
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...
Phantom® Fibula Nail System
FDA UDI
Paragon 28, Inc.·00889795136992·2.6mm Proximal Reamer, Solid, AO Quick Connect
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200191·Paxeon Head, Ceramic Size 36mm M
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001971·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111526320·Ceramic Femoral Head, 36mm, M (0.0 mm)
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIGNATURE Head - BIOLOX Delta
FDA UDI
AMPLITUDE SAS·03701089520805·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
NOVATION
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·November 25, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·June 5, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020