34 results · 12ms · Sources: EU EUDAMED, US FDA

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Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

FDA Recall
Terminated ·Cook Inc.·Product code GBO·December 27, 2019

Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.

FDA Recall
Terminated ·Visx Inc·Product code LZS·May 30, 2007

LADARVision Excimer Laser System.

FDA Recall
Terminated ·Alcon Laboratories, Inc.·Product code LZS·August 1, 2005

STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

FDA Recall
Terminated ·Abbott Medical Optics, Inc.·Product code LZS·May 28, 2013

STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

DIST LAT FEM LOCK PLT, LT

FDA Recall
Terminated ·Zimmer, Inc.·Product code FZS·November 5, 2013

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

FDA Recall
Terminated ·Illumina Inc·Product code PFS·November 6, 2014

STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

FDA Recall
Terminated ·Abbott Medical Optics, Inc.·Product code LZS·May 28, 2013

Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

FDA Recall
Terminated ·Nidek Inc·Product code LZS·February 1, 2017

STAR S4 IR Excimer Laser System; Software Version 5.01 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.02 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

FDA Recall
Terminated ·Nidek Inc·Product code LZS·August 6, 2012

EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.

FDA Recall
Terminated ·Nidek Inc·Product code LZS·March 24, 2015

Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.

FDA Recall
Terminated ·VISX INCORPORATED, A SUBSIDIARY OF AMO INC·Product code LZS·November 17, 2006