54 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·August 9, 2016
Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·June 10, 2013
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·April 17, 2020
Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
FDA Recall
Terminated
·NERL Diagnostics Corporation·Product code JWX·January 15, 2010
Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
FDA Recall
Terminated
·NERL Diagnostics Corporation·Product code JWX·January 15, 2010
S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.
FDA Recall
Terminated
·Nerl Diagnostics LLC·Product code MRV·April 23, 2008
DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.
FDA Recall
Terminated
·Express Diagnostics Int'l., Inc.·Product code JXN·October 4, 2010
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
FDA Recall
Open, Classified
·Sklar Instruments·Product code FZT·December 3, 2024
Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MJK·June 30, 2006
Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by MRL Inc., a WelchAllyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089-Part Numbers-971081,971082,971083,971084.
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MJK·November 15, 2006
Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ--·April 26, 2004
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ·June 15, 2006
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E
FDA Recall
Terminated
·MRL, Inc., A Welch Allyn Company·Product code MKJ·April 28, 2005
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024
Intelli-C, Left side suspended Tabletop, REF: 03400010
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023
Intelli-C, Right side suspended Tabletop, REF: 03400000
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023
Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
FDA Recall
Terminated
·NRT Nordisk Rontgen Teknik A/S Birkegaardsvej 16 Hasselager Denmark·Product code JAA·May 1, 2009
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code ERL·December 15, 2021
Foot Control, SC2100 Product Usage: Electric system
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code ERL·October 6, 2016
Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code ERL·December 18, 2006