5,785 results
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Sources: EU EUDAMED, US FDA
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Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·April 1, 2011
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
FDA Recall
Terminated
·Covidien LLC·Product code DRO·April 8, 2013
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Recall
Terminated
·ASO, LLC·Product code MGO·July 26, 2013
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
FDA Recall
Terminated
·Ebi, Llc·Product code HWC·August 22, 2013
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
FDA Recall
Terminated
·Covidien LLC·Product code MSD·April 23, 2015
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
FDA Recall
Terminated
·Covidien LLC·Product code MSD·April 23, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
FDA Recall
Terminated
·Covidien LLC·Product code NYU·April 23, 2015
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall
Terminated
·Covidien LLC·Product code EZL·January 22, 2016
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
FDA Recall
Terminated
·Covidien LLC·Product code DRO·August 19, 2015
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
FDA Recall
Terminated
·Covidien LLC·Product code NGT·August 6, 2015
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
FDA Recall
Terminated
·Covidien LLC·Product code NGT·August 6, 2015
Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
FDA Recall
Terminated
·Covidien LLC·Product code FFT·April 15, 2016
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
FDA Recall
Terminated
·NeoCoil, LLC·Product code MOS·June 17, 2016
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code GAD·May 25, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023