54 results
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7ms
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Sources: EU EUDAMED, US FDA
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·February 28, 2024
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·September 20, 2023
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·September 3, 2025
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
FDA Enforcement
Class II
·Ongoing·mo-Vis BVBA·January 17, 2024
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·November 13, 2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 24, 2024
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
FDA Enforcement
Class II
·Ongoing·Community Products, LLC·January 28, 2026
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·November 13, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
FDA Enforcement
Class II
·Ongoing·Newport Corp·June 12, 2024
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·July 12, 2023
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·November 13, 2024
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·August 4, 2021
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-001
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 20, 2024
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·November 13, 2024