15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
SMOOTH STEINMANN PINS, TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016745·
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXITOUCH SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2024
ZOLL IVTM SOLEX 7 CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·February 10, 2022
ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HRS·June 29, 2018
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 10, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 13, 2013
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 48MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·January 25, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022