12 results
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33ms
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Sources: EU EUDAMED, US FDA
SHELHIGH NO-REACT DURA SHIELD
FDA 510(k)
FDA Class 2
·Neurology
Modulus
FDA UDI
Nuvasive, Inc.·00195377048813·Modulus ALIF Trial, 6x34x24mm 10°Sm
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982101·posteriors; shade C4; size M; lower jaw
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158216303·RETRACTOR SET TABLE POST FOR BACK HOLDER ABDOMI...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111000850·YASARGIL SCISS STR, S/S 6.25"
Riptide Aspiration System (React 71 Catheter)
FDA 510(k)
FDA Class 2
·Cardiovascular
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 15, 2024
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LGD·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024