50 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
FDA Enforcement
Class II
·Ongoing·Philips North America·January 24, 2024
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 29, 2023
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·May 6, 2020
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·July 6, 2022
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·April 8, 2015
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
FDA Enforcement
Class II
·Terminated·Maquet SAS·July 25, 2018
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 25, 2015
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
FDA Enforcement
Class II
·Terminated·Maquet SAS·June 6, 2018
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
FDA Enforcement
Class II
·Terminated·GETINGE US SALES LLC·April 18, 2018
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 14, 2015
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.
FDA Enforcement
Class II
·Ongoing·Trimble Ab·May 7, 2025
AIM-V Medium REF AV.200/500
FDA Enforcement
Class II
·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
FDA Enforcement
Class II
·Terminated·Epimed International·November 15, 2017