19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LymphaTech Mobile 3D Measuring Tool
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC182512552·ET 25G 1" 1mL Syringe w/ exchangeable needle (TB)
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251255200·ceraMotion® Ti Touch Up Dentin light, 20 g / de...
Navigator Aesthetic Delivery System
FDA 510(k)
FDA Class 2
·General Hospital
LUMIPHASE-R
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046927·LATERAL TRIAL, WIDE, LORDOTIC, 12mm X 23mm X 55...
NA
FDA UDI
aap Implantate AG·04042409261466·Cortical Screw 2.5, small head T8, self-tapp. L 55
SINGLE 8 EXTENSION, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 12, 2011
NATRELLE SILICONE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGEN, INC·Product code FTR·November 5, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 29, 2013
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 3, 2024
UNK HIP ACETABULAR LINER POLY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 26, 2024
UNK HIP FEMORAL HEAD METAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 26, 2024
UNK HIP FEMORAL STEM CHARNLEY
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·April 26, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025