13 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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X-Cube 90
FDA 510(k)
FDA Class 2
·Radiology
Intraoral Scan Body RP
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059075298·
OSTEOTOME PTERYGOID BALL HANDLE
FDA UDI
W.H. Holden, Inc.·D9282004490·
ACUMED
FDA UDI
Acumed LLC·10806378014048·3.5mm x 14.0mm Locking Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378014055·3.5mm x 14.0mm Locking Cortical Screw
CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 15, 2023
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
TAPER SLEEVE ADAPTER 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 1, 2013
HAKIM PROGRAMMABLE VALVE
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·February 8, 2022
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021