23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MISTY-OX PREFILLED HUMIDIFIER, DISP.
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 RECEIVER
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2025
PathLoc-SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
STERIS RESERT XL TEST STRIP
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 RECEIVER
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 24, 2025
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 30, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2012
SMITH & NEPHEW
FDA Adverse Event
Other
·SMITH & NEPHEW·Product code HRX·July 22, 2010
ARCOM 28MM RNGLOC LNR HWALL 23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 25, 2019
28MM DIA COCR MOD HD +3MM NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 25, 2019
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·May 12, 2025
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·May 12, 2025
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·May 12, 2025
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3)
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·May 12, 2025
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·August 28, 2025
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·May 5, 2025
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·July 24, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·July 24, 2025
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·July 24, 2025
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
FDA Recall
Open, Classified
·Dexcom, Inc.·Product code QBJ·July 24, 2025