145 results
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7ms
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Sources: EU EUDAMED, US FDA
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·February 7, 2024
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 2019
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·June 12, 2019
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off
FDA Enforcement
Class II
·Ongoing·Respironics California, LLC·February 3, 2021
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
FDA Enforcement
Class II
·Ongoing·Ethicon, Inc.·May 29, 2024
Halyard, Pain Pack. Kit Code: AMPK48-01.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·June 17, 2026
Halyard, Drape Pack. Kit Code: LMDP36-01.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·June 17, 2026
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·June 17, 2026
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·June 17, 2026
RANDOX Total Bilirubin.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·December 13, 2023
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
FDA Enforcement
Class II
·Ongoing·Aniara Diagnostica LLC·May 20, 2026
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
FDA Enforcement
Class II
·Ongoing·C.R. Bard Inc·June 14, 2023
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·May 24, 2023
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·October 8, 2025
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·December 17, 2025
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·May 24, 2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·May 24, 2023
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·November 23, 2022