17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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