13 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
FDA 510(k)
FDA Class 1
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517574459·CoRoent Ant TLIF Ti, 12x12x40mm 8°
BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 17, 2023
K2M General Instruments
FDA UDI
VB Spine LLC·10888857553897·Parallel Trial Size 8x30x13 mm
Vu cPOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981039318·Implant Non-Tapered 12x14x8mm (Non-Strut)
DIGITAL DIAGNOSTIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CEREC VITABLOCKS MK2
FDA 510(k)
FDA Class 2
·Dental
LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 21, 2022
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
AUTOTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 13, 2011
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017