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

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SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131261526·H11, BTE 13 WL 100 SGR

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

CLYDESDALE PTC SPINAL SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

RENACLEAN SH DIALYZER CLEANING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ALTUM ANTERIOR CERVICAL PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

BELLATEK® ABUTMENT TSV 3.5MM

FDA Adverse Event
Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

ESON 2 NASAL MASK

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

ABUTMENT, PATIENT SPECIFIC, TITANIUM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 29, 2013

ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE)

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 15, 2011

RESOLUTION CLIP DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·August 22, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-4142.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005