20 results · 28ms · Sources: EU EUDAMED, US FDA

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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