27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040133057·Zirlux TR D4 98x14mm
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00126031·
NA
FDA UDI
Smith & Nephew, Inc.·03596010078759·CANN LUM DB STR
MASEL
FDA UDI
Ortho Organizers, Inc.·00190707053970·GeoShapes™ Electrik™ Elastics 1/4"(6.35 mm) Ext...
n/a
FDA UDI
Ortho Development Corporation·00822409072729·Narrow Fully Toothed Broach Size 3
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033426609·
Schaerer Medical USA
FDA UDI
Schaerer Medical Usa, Inc.·00810101300585·36" IA BOARD PAD 3"
INSET GUARD
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 9, 2025
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 3, 2025
INSET GUARD
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 9, 2025
VHS PEDIATRIC HIP SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 21, 2013
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
OBTAPE SLING
FDA Adverse Event
Injury
·MENTOR·Product code FTL·March 10, 2008
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 8, 2025
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 4, 2025