17 results · 31ms · Sources: EU EUDAMED, US FDA

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HA Minuteman G3 MIS Fusion Plate

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE

MaxFuse,VBR, 12 (D) x 14 (W) x 26 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468056155·12 (D) x 14 (W) x 26 (H)

DIATRON PICTUS 400

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACCOLADE HFX FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RADIFOCUS GLIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

PASSEO-18 5/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 6/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 2.5/170/130

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

VICTORY XL SR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC CRMD·Product code DXY·January 13, 2014

CD HORIZON SOLERA

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NKB·July 3, 2011

DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

FDA Adverse Event
Injury ·MPRI·Product code OJX·June 7, 2013

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020