77 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebreathing bag; Teleflex Medical, Bannockburn, IL 60015 USA, Made in UK
FDA Recall
Terminated
·Teleflex Medical·Product code BYW·October 31, 2006
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 28, 2016
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LPH·February 28, 2017
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 28, 2016
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·February 28, 2018
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code HWC·July 27, 2016
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code HWC·July 27, 2016
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code DXT·April 14, 2008
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
FDA Recall
Terminated
·Allen Medical Systems·Product code JEB·October 6, 2017
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·February 28, 2018
Comprehensive Mini Stem, Item No. 113631:
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 19, 2018
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 19, 2018
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LPH·February 28, 2017
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
FDA Recall
Terminated
·Mallinckrodt Inc·Product code IZQ·April 7, 2008
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LZO·February 28, 2017