29 results
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27ms
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Sources: EU EUDAMED, US FDA
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ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·March 20, 2013
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·February 18, 2015
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·August 22, 2018
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120" EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A;
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
FDA Enforcement
Class II
·Completed·CardioTek BV·July 12, 2017
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
FDA Enforcement
Class II
·Terminated·Nucletron BV·November 1, 2017
VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
FDA Enforcement
Class II
·Terminated·Nucletron BV·January 8, 2020
VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020