11 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
FDA Enforcement
Class II
·Ongoing·Unetixs Vascular, Inc.·March 8, 2023
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 20, 2021
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·April 26, 2017
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·March 27, 2019
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·December 18, 2019