59 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Piccolo Composite(R) Distal Volar Radius Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
INFANT, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M
FDA UDI
Intersurgical Incorporated·05030267098101·INFANT, NASAL CANNULA WITH CURVED PRONGS AND TU...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481124174·LOCATOR F-Tx Abutment for Mini Platform GS Conn...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015868·Logic Tray
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075022590·KLEOS PSL METAL MBT 022 UR2 PK5
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481123108·LOCATOR R-TX Attachment System, TS/ET Fixture, ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009133·3.0/4.0mm Cannulated Screwdriver Shaft Long
RITRACT SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694067720·Cannulated 3.0/4.0 Screwdriver Shaft Long Steri...
SETx CERVICAL HOLE PUNCH
FDA UDI
XENCO MEDICAL LLC·B064XMPH11600051·
SETx CERVICAL PLATE INSERTER 9-12MM
FDA UDI
XENCO MEDICAL LLC·B064XMPH11600021·
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-L1(SP142) CDX ASSAY
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145
FDA Recall
Open, Classified
·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·September 26, 2025
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-L1(SP142) Assay
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-Ll (SP142) Assay
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-Ll (SP142) Assay
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-L1 (SP142) Assay
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·Ventana PD-Ll (SP142) Assay
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·VENTANA PD-L1(SP142) CDX ASSAY