11 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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WishBone Medical Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707023197·CALIBRA BANDS 2ND MOLAR n.SUL 27
pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·November 12, 2008
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 16, 2013
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·September 14, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025