13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL TITANIUM MESH SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030249·VANITY 70 SHEER, SIZE ML, SABBIA, GRADUATED COM...
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016
BREMER 3D CROWN FULL ASSEMBLY
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code JEC·April 2, 2013
COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·March 21, 2011
MOORE HIP PROSTHESIS LONG FENESTRATED STEM
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code KWY·April 15, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·H10·Product code KWP·April 4, 2013
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
BD SECONDARY SET C61
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·December 31, 2024
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018
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