20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MAXI-FLOW SUCTION SET W/Y CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756350068·NEURO PACK
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373667·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112335·SURG-I-BAND LIME GREEN
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373674·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373650·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
FDA 510(k)
FDA Class 2
·Orthopedic
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/13 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2020
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 12, 2024
SPEEDICATH COMPLETE CH14 MALE UK
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code GBM·November 30, 2010
ENDURANT II
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·July 2, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 19, 2012
SMR CEMENTLESS MINI STEM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code HSD·June 17, 2020
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015