17 results
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19ms
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Sources: EU EUDAMED, US FDA
NEW IOWA MOTILITY IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
Barricade Coil System
FDA UDI
BALT USA LLC·00818053020797·Barricade Coil System (BCS) is intended for the...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746099434·DB BRACKET MASTER SERIES MAX RIGHT CENTRAL 020X...
Geniant Cranial
FDA UDI
KOH YOUNG TECHNOLOGY INC.·08800050902062·80 mm Fixation Pin
ARCHITECT I2000SR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·November 17, 2022
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CIRRUS OPEN
FDA 510(k)
FDA Class 2
·Radiology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 28, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 7, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2010
BARRICADE COIL
FDA Adverse Event
Malfunction
·BLOCKADE MEDICAL·Product code HCG·September 13, 2017
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code FAJ·January 7, 2016
Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014