BEUDAMED
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    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.

    FDA Recall
    Terminated ·Laserworld Usa Inc·Product code REA·July 19, 2012

    Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·December 22, 2015

    Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".

    FDA Recall
    Terminated ·Product code RGB·November 19, 2010

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    FDA Recall
    Terminated ·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014

    Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696 ; 6) PULMONARY ENDO KIT, Pack Number DYKE1713 ; 7) ENDO KIT, Pack Number DYKE1739 ; 8) ENDOSCOPY PACK-LF , Pack Number DYNJ00339K ; 9) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ0190667K ; 10) CH UMBIL CATH W/INSTR PACK-LF, Pack Number DYNJ0622040Q; 11) ENDOSCOPY-LF, Pack Number DYNJ22890M ; 12) ENDOSCOPIC PACK , Pack Number DYNJ30434I ; 13) ENDOSCOPIC SINUS PACK , Pack Number DYNJ40644A ; 14) ENDOSCOPY PACK, Pack Number DYNJ40645B; 15) ENDO SURGICAL PACK WRO-LF , Pack Number DYNJ41870B ; 16) ENT PK 1008847, Pack Number DYNJ42319C ; 17) ENDOVENOUS BASIC PACK , Pack Number DYNJ42456D ; 18) UROLOGY ENDOSCOPE PACK 319738 , Pack Number DYNJ44638C ; 19) ENDOSCOPY PACK-LF , Pack Number DYNJ53271C ; 20) ENDOSCOPY , Pack Number DYNJ62133; 21) ENDOSCOPY PACK, Pack Number DYNJ62193; 22) ENDOVENOUS CORE PACK, Pack Number DYNJ62557; 23) ENDOSCOPY PACK, Pack Number DYNJ62914; 24) ENDOSCOPIC PACK , Pack Number DYNJ63797A ; 25) ENDOVENOUS ABLATION PACK, Pack Number DYNJ64059; 26) GENERAL ENDOSCOPY PACK, Pack Number DYNJ65371; 27) GYN ENDOSCOPY PACK, Pack Number DYNJ65372; 28) CV NEONATAL PACK, Pack Number DYNJ67356; 29) PEDI ENDO LAP PACK, Pack Number DYNJ68141A ; 30) ENSEMBLE CATHETER DIALYSE-LF, Pack Number DYNJ81973; 31) ENT , Pack Number DYNJ900282I; 32) MUH ENDOCRINE , Pack Number DYNJ901706J; 33) SEPTO/ENDO, Pack Number DYNJ902831D; 34) MODULE ENDO LAP , Pack Number DYNJ903026I; 35) CVOR ENDOSTENT, Pack Number DYNJ906465 ; 36) ENDOSCOPIC SKULL BASE , Pack Number DYNJ906630 ; 37) ENDO CHOLE TRAY , Pack Number LZ7759N; 38) CATHETERIZATION TRAY, Pack Number UVT1175; 39) UMBILICAL VESSEL INSERTION TRA, Pack Number UVT730; 40) TVS4000 ENDOVENOUS PACK, Pack Number TVS4000K

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PPB·April 8, 2024

    Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ; 12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ; 13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ; 14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ; 15) ENDOSCOPY-LF, Pack Number DYNJ22890L ; 16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ; 17) ENDOSCOPY PACK, Pack Number DYNJ50594C ; 18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ; 19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ; 20) ENDOSCOPIC PACK , Pack Number DYNJ54221J ; 21) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478B ; 22) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478D ; 23) ENDO PACK , Pack Number DYNJ56043B ; 24) ENDO PACK , Pack Number DYNJ56043C ; 25) ENDO PACK, Pack Number DYNJ56043F; 26) ENDO PACK , Pack Number DYNJ56043F ; 27) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648B ; 28) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648C ; 29) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648D ; 30) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648J ; 31) ENDO / AUG PACK , Pack Number DYNJ59250A ; 32) ENDO / AUG PACK , Pack Number DYNJ59250B ; 33) PACK ENDO AAA HYBRIDCHRG, Pack Number DYNJ60126B ; 34) DIPASCO GENERAL ENDOCRINE PACK, Pack Number DYNJ60686A ; 35) ENDOSCOPIC PACK , Pack Number DYNJ63797; 36) ENDOSCOPY PACK, Pack Number DYNJ65524; 37) GENERAL ENDOSCOPIC PK , Pack Number DYNJ66034A ; 38) ENT ENDO SINUS WILMINGTON PACK, Pack Number DYNJ66447; 39) ENDOVENOUS PACK , Pack Number DYNJ66596; 40) GENERAL ENDOSCOPIC PACK , Pack Number DYNJ67382B ; 41) PEDI ENDO LAP PACK, Pack Number DYNJ68141; 42) GEN ENDOSCOPY , Pack Number DYNJ81490; 43) PACK ENDOSCOPIC CHOLECYSTE, Pack Number DYNJ81539; 44) ENDO UROLOGY, Pack Number DYNJ83704A ; 45) ENDOSCOPY , Pack Number DYNJ900509N; 46) ENDOSCOPY , Pack Number DYNJ900509O; 47) ENDO OMH, Pack Number DYNJ900525C; 48) MODULE ENDO LAP , Pack Number DYNJ903026F; 49) MODULE ENDO LAP , Pack Number DYNJ903026G; 50) GENERAL ENDOSCOPY , Pack Number DYNJ903421D; 51) CYSTO , Pack Number DYNJ903521A; 52) GENERAL ENDOSCOPY , Pack Number DYNJ903826F; 53) ENDO, Pack Number DYNJ904836A; 54) ENDO, Pack Number DYNJ904836B; 55) ENDO, Pack Number DYNJ904836C; 56) ENDO, Pack Number DYNJ904836D; 57) DIPASCO GENERAL ENDOCRINE , Pack Number DYNJ906574 ; 58) ENDOSCOPIC SKULL BASE , Pack Number DYNJ908362B; 59) ENDOSCOPY KIT , Pack Number P830355A ; 60) ENDOSCOPY KIT , Pack Number P830355AH

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NWU·April 8, 2024

    Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HGB·September 4, 2013

    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGB·April 20, 2022

    KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·December 19, 2024

    KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·December 19, 2024

    Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FGB·April 6, 2016

    KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·December 19, 2024

    11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·April 1, 2022

    KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·December 19, 2024

    Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FGB·April 6, 2016

    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGB·April 20, 2022

    KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·December 19, 2024

    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·April 1, 2022

    Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FGB·September 25, 2023

    Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FGB·April 6, 2016