18 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·December 8, 2020
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code MTF·September 30, 2024
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·December 8, 2020
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·December 8, 2020
Ventana HE 600 System, automated slide preparer, for use in laboratories.
FDA Recall
Open, Classified
·Ventana Medical Systems Inc·Product code KPA·June 1, 2022
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JZO·August 21, 2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JZO·August 21, 2024
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·September 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·September 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·September 29, 2023
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·March 26, 2024
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JZO·August 11, 2022
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code QLU·August 25, 2021
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Recall
Open, Classified
·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·August 25, 2021
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro) Part Number: 0020302601
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code N/A·August 25, 2021
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GKP·February 22, 2022
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297
FDA Recall
Open, Classified
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·December 30, 2021