150 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
FDA Recall
Terminated
·Kim's Trading Inc·Product code LPM·May 17, 2010
Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA
FDA Recall
Terminated
·Nonin Medical, Inc·Product code DQA·October 11, 2007
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code HSD·August 31, 2017
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWS·August 31, 2017
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code KIM·September 4, 2018
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
FDA Recall
Terminated
·Medivators, Inc.·Product code FKQ·April 20, 2021
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·September 3, 2014
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
FDA Recall
Terminated
·ShinChang Medical Co., Ltd. 144 1gongdan-Ro Gumi Korea (the Republic of)·Product code FMF·August 24, 2018
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Recall
Terminated
·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code HWT·May 3, 2013
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Recall
Terminated
·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·March 4, 2015
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·March 4, 2015
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LRY·January 8, 2016
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·November 10, 2014
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LZO·November 7, 2014
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·July 11, 2013
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWL·June 21, 2018
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·November 8, 2016
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018