30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252024012·ANODYNE CERVICAL SCREW - VARIABLE SELF TAPPING...
Aztec
FDA UDI
Aztecmed/Ent LLC·B87110240120·Stevens Tenotomy Scissors, straight
Zavation
FDA UDI
Zavation LLC·00842166122246·Self Drilling Fixed Screw, 4.0mm x 12mm
EndoVive
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00813939020243·
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
FDA 510(k)
FDA Class 2
·Cardiovascular
DOC BAND
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·January 7, 2025
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 22, 2024
SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 18, 2021
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·March 27, 2013
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·March 14, 2011
INTERLINK CATHETER EXTENSION SET/MALE LUER
FDA Adverse Event
Malfunction
·AIBONITO·Product code FPA·April 5, 2008
SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 18, 2021
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
FDA Recall
Open, Classified
·HUMAN MED AG Wilhelm-Hennemann-Str. 9 Schwerin Germany·Product code QPB·October 18, 2024
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
FDA Enforcement
Class II
·Ongoing·HUMAN MED AG·March 12, 2025
TREO ABDOMINAL STENT-GRAFT SYSTEM
FDA Adverse Event
Injury
·BOLTON MEDICAL, INC.·Product code MIH·January 17, 2024
BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 22, 2020
RELION INSULIN SYRINGE
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·May 4, 2020