21 results
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29ms
·
Sources: EU EUDAMED, US FDA
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
FDA 510(k)
FDA Class 2
·Radiology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964018884·The ENDO CARRY-ON Procedure Kit contains all of...
RMO
FDA UDI
Rmo, Inc.·00885797099754·LING RETNR BOND 4X4 6 CASE KIT
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0025311·CC/ Dentine D-A1
Portex
FDA UDI
ICU MEDICAL, INC.·10351688408723·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450136676·
NA
FDA UDI
aap Implantate AG·04042409048401·K-wire with trocar point, ø2.5, L 310
PHACOFRAGMENTATION SYSTEM MEGATRON
FDA 510(k)
FDA Class 2
·Ophthalmic
LACTOSORB ETHMOID STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·March 13, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·February 16, 2011
HAKIM PROGRAMMABLE VALVE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MEDOS S.A·Product code JXG·February 26, 2008
RESTORE PRIME
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·March 5, 2012
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
ITREL 3
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·March 5, 2012
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025