12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONOCRYL UD 27IN USP2-0
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAN·October 25, 2024
MONOCRYL UD 27IN USP2-0
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAN·October 25, 2024
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295233558·P.F.C. SIGMA TIBIAL COMPONENT ALL POLY CURVED 4...
THERMACLEAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dexter L6 System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2014
URS Ø5 L45
FDA Adverse Event
Malfunction
·SYNTHES·Product code KWP·February 14, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·January 13, 2011
Depuy P.F.C. E Knee System, all polyethylene curved tibial component, Sz 4, 15 mm; Ref 96-0653.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 8, 2014
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658
FDA Recall
Terminated
·Zimmer, Inc.·Product code JDI·December 10, 2013