11 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code DWJ·July 21, 2017
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·December 5, 2014
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·February 7, 2018
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·February 4, 2015
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FSM·November 15, 2016
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FCH·November 15, 2016
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code LXH·November 15, 2016
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 1, 2022
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
FDA Recall
Terminated
·ConMed Corporation·Product code GEI·May 8, 2014
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code OYK·November 17, 2011
Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USA Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GYK·December 22, 2010