13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dia-Cem
FDA 510(k)
FDA Class 2
·Dental
BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTO·April 6, 2022
BD BBL™ Taxo™ A
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902315521·BD BBL™ Taxo™ A Differentiation Test for Group ...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021963·OPTYC MBT CUS HK 0T +3A 022 LL
GENERUS® II
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K31552991·GENERUS® II Base Rx 022 UL/5-5 CS HK
CONVENTUS DRS
FDA 510(k)
FDA Class 2
·Orthopedic
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
BD BBL¿ TAXO¿ A
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTO·November 22, 2024
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 22, 2011
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 17, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 17, 2013
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022