5 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL5059-32 HAL5071-133 HAL5071-145 HAL5071-163 HAL5071-181 HAL5071-572 HOWHB-NST-6828-7-791 HOWHB-NST-6828-7-792 KOMK-2000-65 KOMKM-004 KOMKM-005 KOMKM-101 KOMKM-101C KOMKM-102 KOMKM-234 KOMKM-275R KOMKM-3101 KOMKM-3107 KOMKM3-225 KOMKM-325R KOMKM-619 KOMKM-660 KOMKM-693 LIN5023-170 MICSO-601 MICSO-610 MICSP-414A MICZO-062 MICZO-7052 MMM5756 STR2108-100 STR2108-102 STR2108-105 STR2108-107-4 STR2108-109 STR2108-110 STR2108-113 STR2108-115 STR2108-118 STR2108-120 STR2108-125 STR2108-140 STR2108-140-6 STR2108-148 STR2108-150 STR2108-150S2 STR2108-151 STR2108-152 STR2108-152-6 STR2108-158 STR2108-160 STR2108-161-2 STR2108-183 STR2108-185 STR2108-189 STR2108-192 STR2108-218 STR2108-302 STR2108-309 STR2108-351 STR2108-356 STR2296-3-103 STR2296-3-105 STR2296-3-111 STR2296-3-115 STR2296-3-125 STR2296-3-212 STR2296-3-225 STR2296-33-105 STR2296-33-111 STR2296-33-125 STR2296-3-412 STR2296-3-414 STR2296-3-511 STR277-88-100 STR277-88-125 STR277-96-250 STR277-96-275 STR277-96-277 STR277-96-325 STR277-96-326 STR298-97-100 STR4111-107-090 STR4125-089-075 STR4125-097-090 STR5100-137-233 STR5301-30-172 STR5301-40-33 STR6113-127-90 STR6125-89-75 SYN11-2217 SYN11-3500 SYN11-3534 TER98-0702-1234-9 ZIM5979-95-35 and ZIM5979-95-41 Surgical instruments motors and accessories are AC-powered, battery-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue.
FDA Recall
Terminated
·Sterilmed Inc·Product code GFA·August 8, 2008
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014