29 results · 11ms · Sources: EU EUDAMED, US FDA

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Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''

FDA Recall
Terminated ·Eatonform Inc·Product code NXQ·August 2, 2006

NX3 Try-In Gel. The product is used as a tooth shade resin material.

FDA Enforcement
Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·September 25, 2013

NX3 Try-In Gel. The product is used as a tooth shade resin material.

FDA Recall
Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code EBF·September 13, 2013

19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

FDA Recall
Terminated ·AGFA Corp.·Product code MQB·June 30, 2010

Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

FDA Recall
Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012

Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

FDA Recall
Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012

NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-2, 5082-104-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113 and 30502-213 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-2 and 636-5084-104-2 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20

FDA Recall
Terminated ·Suntech Medical, Inc.·Product code DXQ·June 3, 2019

NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-1 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503558X

FDA Recall
Terminated ·Cordis Corporation·Product code DXQ·July 21, 2006

NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - firm on label is Welch Allyn, Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #30502-110S, firm on label is Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #5084-101-1, firm on label is Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503658

FDA Recall
Terminated ·Cordis Corporation·Product code DXQ·July 21, 2006

Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.

FDA Recall
Terminated ·Laborie Medical Technologies Cor·Product code EXQ·April 9, 2009

Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DXQ·January 5, 2018

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-1 - Arden, Skaneateles, NY.

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Firm on label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corporation, McGaw Park, IL 60085-6787 USA''

FDA Recall
Terminated ·Welch Allyn Inc·Product code DXQ·October 27, 2003