18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VINTAGE Art LF
FDA 510(k)
FDA Class 2
·Dental
Temptation NOW® A1 76g
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002042·Crown and Bridge Temporary Resin
Temptation NOW® A1 76g
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003845·Crown and Bridge Temporary Resin
LACTOSORB® SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055714·
Low Profile Acetabular Reamer 51
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057541·
LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HXX·September 14, 2020
LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HXX·September 14, 2020
LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HXX·September 14, 2020
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
S8 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MPS ACACIA MEDFLO ELASTOMERIC PUMP
FDA 510(k)
FDA Class 2
·General Hospital
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 7, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HWC·September 14, 2020
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024