52 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
FDA Recall
Terminated
·Neo Medical, Inc.·Product code LRS·April 5, 2011
Material 301-00, INSERTION TRAY , NeoMedical Incorporated, V-CATH INSERTION TRAY, REF 30I -00, STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, IHI COMPLIANT, Manufactured by Centurion Medical Products Corp. for: NeoMedical, 42514 Albrae Street, Fremont, CA 94538 (888) 450-3334 " FAX (510) 353-9025 FACILITATES LINE PLACEMENT
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code LRS·March 31, 2011
NeoMedical Incorporated, V -Cath Insertion Tray, REF301-00, Sterile.
FDA Recall
Terminated
·Centurion Medical Products·Product code LRS·June 2, 2010
VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.
FDA Recall
Terminated
·Marina Medical Instruments Inc.·Product code HDQ·April 9, 2009
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·February 11, 2015
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
FDA Enforcement
Class II
·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
FDA Recall
Terminated
·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·October 22, 2015
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctive with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·December 7, 2016
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·April 17, 2013
Neos Vanadium Excavator Part Number 591/0 SCHE
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/0-6
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/3 SCHE
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/4
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/5 SCHE
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/2
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/0
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/1
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
FDA Recall
Terminated
·Westmed, Inc.·Product code BYE·January 15, 2019
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
FDA Recall
Terminated
·Westmed, Inc.·Product code BYE·January 15, 2019
Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
FDA Recall
Terminated
·Westmed, Inc.·Product code BYE·January 15, 2019