BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    Dr. pen Microneedling System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROFILE

    FDA UDI
    Medos International Sàrl·10886705010462·PROFILE CANNULATED INTERFERENCE SCREW ROUND HEA...

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506082245·forceps atraumatic, DEBAKEY, straight, 2.7mm, 20cm

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158212244·FORCEPS DEBAKEY ATRAUMATIC TISSUE 2.7MM TIP STR...

    VERSANT KIDCO

    FDA UDI
    FGX INTERNATIONAL INC.·00193033307793·

    SOLEA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAVLOCK

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·August 27, 2024

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 7, 2008

    PENTA PADDLE LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 15, 2011

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·July 16, 2013

    VITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·June 21, 2017

    VITEK 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

    Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420

    FDA Recall
    Terminated ·Mitek Worldwide·Product code HWC·February 28, 2003

    Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420

    FDA Recall
    Terminated ·Mitek Worldwide·June 16, 2003

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

    FDA Enforcement
    Class I ·Completed·DATEX--OHMEDA, INC.·November 6, 2024

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020