22 results · 23ms · Sources: EU EUDAMED, US FDA

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NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT

FDA 510(k)
FDA Class 2 ·Orthopedic

Grid Biopsy Unit: lateral for GE 8-Channel Breastc

FDA UDI
Noras MRI products GmbH·04251269202377·

TORNIER INSITE FT SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

DISCOVERY FACET SCREW FIXATION SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·May 14, 2013

PLATE 100 TUBULAR 6 HOLE

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDL·May 18, 2011

ENDOPOUCH RETRIEVER SPEC BAG

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 12, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022