38 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L
FDA 510(k)
FDA Class 2
·Cardiovascular
DEFENDO Disposable Biopsy Valve
FDA UDI
MEDIVATORS INC.·00677964065064·DEFENDO Disposable Biopsy Valve
Mirror™
FDA UDI
CAYENNE MEDICAL, INC.·M543100319·Tibial insert, flat (RM/LL-44x11mm)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450186077·
A-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361005414·ALIFT IBC, STRAIGHT, 19MM
Zavation
FDA UDI
Zavation LLC·00197157007270·Recessed ALIF Screw Inserter, 19mm
PC
FDA UDI
Allied Medical, LLC·00026072021101·REG O2 PRE-SET @ 50 PSI
Femoral Notch Reamer Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042103·
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·August 9, 2011
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·August 9, 2011
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 3, 2023
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PASCAL STREAMLINE PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 10, 2010
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 10, 2022
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013
ACCESS ACCUTNI+3 REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·September 18, 2014
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·May 16, 2011
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015