16 results
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6ms
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Sources: EU EUDAMED, US FDA
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Enforcement
Class II
·Ongoing·CORENTEC CO., LTD·June 12, 2024
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·May 7, 2025
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
IBA Proton Therapy System - PROTEUS 235
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 18, 2026
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 18, 2024
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·June 12, 2024
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·June 8, 2022
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·November 22, 2023
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·May 1, 2024
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 16, 2022
Proteus 235-Proton Therapy System
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 4, 2021
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 15, 2021
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 28, 2024
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
FDA Enforcement
Class II
·Ongoing·IN MY BATHROOM LLC·October 12, 2022
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; e. CRANIOTOMY CDS, Model Number: CDS981753L; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; h. DBD-JOINT INJECTION TRAY, Model Number: DYNDH1722; i. ENS STERILE POUR IMPLANT-LF, Model Number: OST011E; j. FREE FLAP LOWER EXT-LF, Model Number: DYNJ909168; k. FREE FLAP UPPER EXT-LF, Model Number: DYNJ909169; l. HYBRID PACK, Model Number: DYNJ56907D; m. IR ARM PACK, Model Number: DYNJ50712C; n. LOWER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0204D; o. MURRIETA PACK, Model Number: DYNJ69312, DYNJ69312A; p. OASC IVF PACK, Model Number: DYNJ53035B; q. PERIPHERAL NERVE BLOCK KIT, Model Number: DYNJRA1619; r. RO VASCULAR EXTREMITY PK-LF, Model Number: PHS392881009C; s. SCO ARTHROSCOPY, Model Number: DYNJ906551A; t. SHOULDER BLOCK KIT , Model Number: DYKS1241A; u. SHOULDER PACK-LF, Model Number: PHS41748D; v. TAA AAA, Model Number: DYNJ63339D; w. TOTAL HIP PACK-LF, Model Number: DYNJ51672J, DYNJ51672K, DYNJ51672L; x. TOTAL KNEE REPLACEMENT, Model Number: DYNJ908420; y. TUNNEL PACK, Model Number: DYNJ58127B; z. UPPER EXTREMITY BLOCK PACK-RX, Model Number: SPEC0205F; aa. US JOINT KIT, Model Number: DYNJRA1944; bb. VASCULAR EXTREMITY PACK, Model Number: DYNJ63373B, DYNJ63373C, DYNJ63373D, DYNJ63373F;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023