17 results · 19ms · Sources: EU EUDAMED, US FDA

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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