68 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code LYY·August 19, 2020
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
FDA Recall
Terminated
·Gentueri Inc·Product code JSM·July 6, 2020
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
FDA Recall
Terminated
·Exactech, Inc.·Product code KWS·October 6, 2020
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Recall
Terminated
·Exactech, Inc.·Product code KWS·October 6, 2020
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code DWS·February 6, 2020
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
FDA Recall
Terminated
·Elekta Inc·Product code HAW·March 30, 2020
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
FDA Recall
Terminated
·Hardy Diagnostics·Product code PQZ·October 6, 2020
Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code CCW·July 6, 2020
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020
OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code MQV·April 6, 2020
OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020