19 results
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45ms
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Sources: EU EUDAMED, US FDA
UShare Medical Inc.
Manufacturer
🇨🇳 China·1 Importer
INTRAMED
Importer
🇦🇹 Austria·9 Manufacturers
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
FDA Enforcement
Class II
·Terminated·Progressive Medical Inc·November 21, 2012
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 18, 2011
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 7, 2016
ACCESS® ACCUTNI¿ REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 12, 2011
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
FDA Recall
Terminated
·Progressive Medical Inc·Product code GDI·December 9, 2011
Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
FDA Recall
Terminated
·Medtronic Inc·Product code LDF·February 6, 2009
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.
FDA Recall
Terminated
·Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland·Product code NIQ·August 6, 2009
Accuramed BV
Importer
🇧🇪 Belgium·7 Manufacturers
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices