12 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Hot and Cold Compression System (A02-C-032)
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113417·IMPLANT KNIFE 5.2MM (BX/5)
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
FDA 510(k)
FDA Class 2
·Neurology
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k)
FDA Class 2
·Microbiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 12, 2010
BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·December 22, 2022
LUMAX 340 HF-T
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code MRM·December 4, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 29, 2013
NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025