14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SEARE BIOMEDICAL SILICONE SHEETING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983041·posteriors; shade B1; size XL; lower jaw
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
FDA 510(k)
FDA Class 3
·Cardiovascular
Full Digital Colour Doppler Ultrasonic Diagnostic System
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Zimmer, Inc.·00889024218291·
NexGen®
FDA UDI
Zimmer, Inc.·00889024218284·
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
UNKNOWN JUGGERKNOT 1.4
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBI·February 28, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 4, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
ENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 24, 2025
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024