62 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sterile Custom Packs to be used in surgical procedures.
FDA Recall
Terminated
·American Contract Systems Jackson Pointe Commerce·Product code PKE·April 13, 2020
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Enforcement
Class II
·Terminated·Medtronic·December 28, 2016
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
FDA Enforcement
Class II
·Terminated·Invacare Corporation·December 9, 2020
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·July 22, 2021
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·September 8, 2021
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Recall
Terminated
·Vortran Medical Technology 1, Inc·Product code BTL·April 20, 2017
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Enforcement
Class II
·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 13, 0012
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·November 4, 2008
3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019