170 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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lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
FDA Enforcement
Class II
·Terminated·Invatec Llc·June 12, 2013
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·August 14, 2013
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
FDA Recall
Terminated
·Invatec Llc·Product code DXE·March 4, 2009
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
CMExpress Microbore Sets, REF: A120-160CYFRV
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
BodyGuard Microset, REF: A120-160XSFK
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
CMExpress Microbore Sets, REF: A120-161C
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
BodyGuard Microset, REF: A120-161XPSV
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
CMExpress Microbore Set, REF: A120-160CRV
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
BodyGuard Microset, REF: A120-003XS2YV
FDA Recall
Terminated
·CME America, LLC·Product code FPA·June 16, 2020
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Recall
Terminated
·CME America, LLC·Product code FRN·July 30, 2020
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00 Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00
FDA Recall
Terminated
·CME America LLC·Product code FRN·February 27, 2020