13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SILON SCAR STRIPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074549743·DISTRACTOR/TRIAL 2982036 10 X 36MM L
PROPELLER HEAD
FDA UDI
Biomet Orthopedics, LLC·00880304416864·
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982036·posteriors; shade A4; size M; upper jaw
Sklar
FDA UDI
SKLAR CORPORATION·10649111376771·MICRO MOSQ FCP STR 1X2 4 3/4 IN
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NeuroBlate System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·January 20, 2025
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 9, 2022
STRAIGHT TIP T25 DRIVER STANDARD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·February 28, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LFX·February 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
D & C Kit, part number CMP1466(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017