14 results
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19ms
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Sources: EU EUDAMED, US FDA
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
FDA 510(k)
FDA Class 2
·Radiology
STAR
FDA UDI
Stryker GmbH·00886385017839·Talar M/L Cut Guide Assembly Right, XX Small
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605487·MAQUET 1130 ORTHOPEDIC 2" SOFTCARE PLUS
A&E Medical / Rotating Surgical Punches
FDA UDI
A & E MEDICAL CORPORATION·20841291105135·Rotating Surgical Punches, 20 per Box
MALE LATEX CONDOM WITH RIBBED SURFACE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARDYDISK, NITROFURANTOIN
FDA 510(k)
FDA Class 2
·Microbiology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 6, 2025
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·TRIVASCULAR, INC.·Product code MIH·April 24, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 6, 2011
PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPA·July 22, 2008
ADVIA CENTAUR XP TOXOPLASMA (TOXO M) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·February 28, 2017
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014