12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIXION INTERLOCKING NAIL (FIXION IL NAIL)
FDA 510(k)
FDA Class 2
·Orthopedic
DURA-CUF
FDA UDI
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682110365·DURA-CUF, INFANT, 2 TB SCREW, 08 - 13 CM, SINGLE
CUSTOMED
FDA UDI
CUSTOMED INC·M20890027833·DISPOSABLE VAGINAL SPECULUM MEDIUM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450239605·
DIRECT TIBC CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LORENZ RESORBABLE DISTRACTOR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LNQ·March 13, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018