10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MediClear PreOp
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
FDA 510(k)
FDA Class 2
·Dental
PERIPATCH ENDO-SLEEVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
FUJIFILM BALLOON BS-4
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDA·January 14, 2021
FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·June 9, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
HEALTHPLUS·Product code ITJ·June 11, 2013
SURGICAL HANDPIECE 3555
FDA Adverse Event
Injury
·KALTENBACH & VOIGT GMBH·Product code EKK·September 17, 2008
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026