23 results
·
76ms
·
Sources: EU EUDAMED, US FDA
CADD LEGACY PLUS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD, INC.·Product code FRN·August 15, 2011
DA VINCI SP
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·July 7, 2022
GORE DUALMESH® PLUS BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code FTL·October 4, 2019
GYNECARE MESH UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTM·May 16, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 23, 2018
PHACO (PHGSE)107
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code LRO·January 11, 2011
CARELINK PERSONAL MMT-7333
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·August 25, 2023
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code NZT·November 19, 2019
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·April 8, 2013
OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
FDA Recall
Terminated
·OPTI Medical Systems, Inc·Product code CGZ·March 15, 2011
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, 2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code MMP·September 27, 2006
Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code MMP·September 27, 2006
Duomed Scandinavia A/S
Importer
🇩🇰 Denmark·23 Manufacturers
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Wellkang Ltd
Authorized representative
259 Manufacturers·3500 Devices
Ortho Organizers GmbH
Importer
🇩🇪 Germany·34 Manufacturers
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
Plandent Oy
Importer
🇫🇮 Finland·43 Manufacturers
Caretechion GmbH
Authorized representative
🇩🇪 Germany·158 Manufacturers·1463 Devices