14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRELLIS-8 PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
D-Fine Double Diamond™ Trial Kit #04
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001731·Dental burnisher
Life Instruments
FDA UDI
Life Instrument Corporation·M930813090400·Spinal Curette 9" #4
K2M General Instruments
FDA UDI
VB Spine LLC·10888857561281·Box Chisel Size 6 mm
UniTip Catheter
FDA UDI
Unisensor AG·07640172972380·
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PALAMED
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MANUFACTURING·Product code GEI·November 19, 2013
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 24, 2013
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 16, 2011
RESTORE ADVANCED RECHARGABLE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·August 21, 2008
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 24, 2014
Merit MAK Mini Access Kit, 4 French (1.3mm)
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DRE·July 20, 2004