186 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 29, 2020
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Enforcement
Class II
·Ongoing·Icotec Ag·January 17, 2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA Enforcement
Class II
·Ongoing·Cook Medical Incorporated·May 22, 2024
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·April 13, 2022
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Meditec, Inc.·August 18, 2021
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
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
RANDOX Total Bilirubin.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·December 13, 2023
2008T HD SYS. CDX BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 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
Optima XR646 HD. X-Ray imaging system.
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·February 12, 2025