BEUDAMED
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    CATHETER ADAPTER SEALING CAP NO. 48-1028-9

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950022663·SUCTION TIP MCKESSON TYPE TIP OPENING 4MM 9" 23CM

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746096679·DB BKT MASTER IBD UL CUSP 018 T-7 A+10 R=0

    MICRO BAYONET BIOPSY FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896070363·MICRO BAYONET BIOPSY FORCEPS STRAIGHT TIP 360° ...

    MICRO NEURO BIOPSY FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929000060·MICRO NEURO BIOPSY FORCEPS LIGHTWEIGHT GOLFBALL...

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746094576·DB BRACKET MASTER SERIES MAX LEFT CUSPID 018 TQ...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659210271·Bone wire in coils of 10m _x000D_...

    Bone wire in coils of 10m 0.6mm

    FDA UDI
    mahe medical gmbh·EMAH00409000060·Bone wire in coils of 10m 0.6mm

    900-006 Concave Chin Sizer Set

    FDA UDI
    IMPLANTECH ASSOCIATES, INC.·M7249000061·Chin Sizer Set

    IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIFEBRIDGE B2T, MODEL 7001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 2, 2019

    BIPOLAR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDH·June 27, 2014

    COOL PATH 7F, 1304-CP-7-25-M

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·October 22, 2010

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·December 26, 2012

    UNK JUVEDERM VOLUX

    FDA Adverse Event
    Injury ·ALLERGAN (PRINGY)·Product code LMH·March 8, 2024

    BASE SYSTEM,ILLUMENA,NON-OEM

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM·Product code DXT·November 28, 2022

    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 25, 2018

    BASE SYSTEM,ILLUMENA,NON-OEM

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM·Product code DXT·October 5, 2021

    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·May 21, 2018