36 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·March 6, 2019
Convenience Kit, BREAST HERNIA DYNJ909125G
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
MAGNETOM Connectom.X. Model Number: 11371480.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
BIOGRAPH One (DE). Model Number: 11689172.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·November 19, 2025
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
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·November 19, 2025