100 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Enforcement
Class II
·Ongoing·PATH·December 24, 2025
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
Multichem P, Part Code 08P90-10
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·November 19, 2025
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3762; 35" (89 cm) Appx 6.6 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Low Protein Binding Filter, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3763
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025