BEUDAMED
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    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·September 14, 2016

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·August 31, 2022

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 20, 2013

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 17, 2016

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·April 26, 2017

    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·October 21, 2020

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·March 31, 2021

    Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number DYNDH1697; 11) PAIN MANAGEMENT PACK, Pack Number DYNDH1697A ; 12) EPIDURAL TRAY , Pack Number DYNDH1739; 13) PAIN MANAGEMENT TRAY, Pack Number DYNDH1823; 14) PAIN KIT MARSHFIELD , Pack Number DYNDH1842; 15) PAIN TRAY , Pack Number DYNDH1938; 16) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290C ; 17) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290D ; 18) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290F ; 19) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378G ; 20) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378I ; 21) STERILE PAIN PACK-LF, Pack Number DYNJ0384670F ; 22) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265G ; 23) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265I ; 24) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265J ; 25) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265K ; 26) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265L ; 27) EPIDURAL PAIN INJ (O.I) PK-LF, Pack Number DYNJ0429265M; 28) PANCREAS DONOR PACK-LF, Pack Number DYNJ0429318F ; 29) MINOR ACUTE PACK-LF , Pack Number DYNJ0484979C ; 30) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0487701G ; 31) LOCAL PACK-LF , Pack Number DYNJ0554526I ; 32) ESI PACK-LF , Pack Number DYNJ0562716G ; 33) PAIN MANAGEMENT - EDOC PACK-LF, Pack Number DYNJ0625993I; 34) BGMC MJR ORAL/MAXILLO PACK-LF , Pack Number DYNJ0664646B ; 35) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964J ; 36) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964K ; 37) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964L ; 38) DSA PACK-LF , Pack Number DYNJ0843713D ; 39) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0904575C ; 40) LOCALS PACK-LF, Pack Number DYNJ0939707; 41) EP TRAY , Pack Number DYNJ21808D ; 42) PAIN MANAGEMENT , Pack Number DYNJ26879B ; 43) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384L ; 44) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384M ; 45) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384N ; 46) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384O ; 47) FACET , Pack Number DYNJ28549D ; 48) PAIN MANAGEMENT PACK, Pack Number DYNJ30042A ; 49) PAIN MANAGEMENT KIT , Pack Number DYNJ30500; 50) PAIN MANAGEMENT KIT , Pack Number DYNJ30500A ; 51) PAIN BLOCKS PACK, Pack Number DYNJ31717B ; 52) PAIN BLOCKS PACK, Pack Number DYNJ31717C ; 53) PAIN BLOCKS PACK, Pack Number DYNJ31717D ; 54) RADIOLOGY EPIDURAL 0906005-LF , Pack Number DYNJ32775K ; 55) UNIVERSAL BLOCK TRAY;EXT LINE , Pack Number DYNJ33057; 56) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352B ; 57) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352C ; 58) LOCAL BASIC , Pack Number DYNJ34418I ; 59) LOCAL BASIC , Pack Number DYNJ34418L ; 60) LOCAL BASIC , Pack Number DYNJ34418M ; 61) PATIENT PREP TRAY , Pack Number DYNJ34489D ; 62) SOFT PAIN TRAY-LF , Pack Number DYNJ35270C ; 63) PAIN MANAGEMENT , Pack Number DYNJ36528A ; 64) PAIN MANAGEMENT , Pack Number DYNJ36528B ; 65) LOCAL PROCEDURE PACK, Pack Number DYNJ38148C ; 66) LOCAL PROCEDURE PACK, Pack Number DYNJ38148D ; 67) BASIC PAIN PACK-LF, Pack Number DYNJ38623F ; 68) BASIC PAIN PACK-LF, Pack Number DYNJ38623G ; 69) BASIC PAIN PACK-LF, Pack Number DYNJ38623I; 70) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number DYNJ39178B ; 71) PAIN PROCEDURE PACK , Pack Number DYNJ40804D ; 72) BLOCK PACK, Pack Number DYNJ44205B ; 73) BLOCK PACK, Pack Number DYNJ44205D ; 74) EP PACK 319704, Pack Number DYNJ44602C ; 75) PAIN PACK , Pack Number DYNJ45913A ; 76) PAIN PACK , Pack Number DYNJ45913B ; 77) PAIN PACK , P

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Enforcement
    Class II ·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Enforcement
    Class III ·Terminated·Ki Mobility Llc·January 19, 2022

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014