30 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
FDA 510(k)
FDA Class 2
·Cardiovascular
BI-METRIC XR-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650572·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555075·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239908·
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000479·MCK Patellofemoral Component
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000391·FUKUSHIMA SUCTION TUBE
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804120·FUKUSHIMA SUCTION TUBE
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107026·TRIAL 90-SRK-180412 POLY PS 4X12MM
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOLOX DELTA CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 1, 2023
KIWI COMPLETE VACUUM DELIVERY SYSTEM
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code HDB·December 7, 2018
MCK TIBIAL ONLAY INSERT-SZ 3-8MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·September 12, 2017
BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 18, 2023
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 27, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 18, 2023
BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 18, 2023