15 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LENSAR Laser System - fs 3D (LLS-fs 3D)
FDA 510(k)
FDA Class 2
·Ophthalmic
Temptation NOW® A3 76g
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002066·Crown and Bridge Temporary Resin
Temptation NOW® A3 76g
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003869·Crown and Bridge Temporary Resin
LACTOSORB® SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055738·
Low Profile Acetabular Reamer 53
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057565·
TRACTION SYSTEM, DIGIT-TRAC 930
FDA 510(k)
FDA Class 2
·Physical Medicine
STERISPINEPS PEDICLE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 28, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014
CRIT-LINE BLOOD CHAMBER
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KOC·July 21, 2018
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023