34 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Air Compression Therapy Device, model HW6007
FDA 510(k)
FDA Class 2
·Physical Medicine
N/A
FDA UDI
Smith & Nephew, Inc.·00885556603390·MTO AWL 1.8MM W/REMOVABLE HDL
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706954·Micro Osteotome 7" (18cm), 4mm wide, straight
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824166·Pratt Rectal Probe, 19.7cm shaft
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
FDA 510(k)
FDA Class 2
·Neurology
POLYCARBOXYLATE (PCA) CEMENT
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 27, 2020
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 28, 2025
EMBLEM MRI S-ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·July 18, 2023
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 4, 2026
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 8, 2021
BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 16, 2021
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
EMBLEM MRI S-ICD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·May 20, 2026
EMBLEM S-ICD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·May 20, 2026
ACT-LR CUVETTE ASSAY (HEMOCHRON ELITE SYSTEM)
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORP.·Product code JBP·February 15, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·October 22, 2008