BEUDAMED
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    CARPENTIER BI-CAVAL FEMORAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181293·Integra® Jarit® Blake Gall Stone Forceps, 8-1/4...

    ON-BOARD IMAGER DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRONG DENTAL HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 13, 2023

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 15, 2017

    PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code LWS·October 3, 2014

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 29, 2013

    ACCESS

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 25, 2011

    PERF CON TIB BRG LRG 22X60

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    NON-POROUS PERF TIB TRAY-LGE

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    PERF ANAT TIBIAL STEM 120X14X5

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024