10 results
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17ms
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Sources: EU EUDAMED, US FDA
STERILIZATION PROCESS CHANGE BOUNDARY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERTEBRIS
FDA UDI
Richard Wolf GmbH·04055207020746·GRASPING FORCEPS Ø 3.4MM WL 240MM TL 330mm, re...
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331151279·erich arch bar material, package of 12, 5 1/8" ...
Medical RF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PASCAL STREAMLINE PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 20, 2014
DURALOC 300 SERIES 60MM OD
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code LPH·October 16, 2012
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 15, 2015
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021