BEUDAMED
    27 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Enforcement
    Class I ·Terminated·I-Flow Corporation·September 5, 2012

    CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.

    FDA Recall
    Terminated ·Hamilton Co·Product code JJE·September 26, 2011

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Enforcement
    Class II ·Terminated·I-Flow LLC·June 12, 2013

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Enforcement
    Class II ·Terminated·I-Flow LLC·June 12, 2013

    Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNT·April 24, 2017

    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.

    FDA Recall
    Terminated ·Philips Ultrasound, Inc.·Product code LLZ·May 15, 2015

    CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJK·May 20, 2014

    Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code MJQ·July 4, 2008

    NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).

    FDA Recall
    Terminated ·Biomerieux, Inc.·Product code JJQ·February 26, 2004

    EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures.

    FDA Recall
    Terminated ·St. Jude Medical·Product code JOQ·March 23, 2009

    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code JJQ·January 12, 2011

    Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, LIFESCAN, a Johnson & Johnson Company, Milpitas California 95035, For Sale Outside of the USA and Canada, Lot 1666680A Exp. 2003-11. Product is packed two vials of 25 strips per vial.

    FDA Recall
    Terminated ·Product code JJQ·October 8, 2002

    EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function.

    FDA Recall
    Terminated ·EP Medsystems·Product code JOQ·April 4, 2006

    Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25 Test Srips, LIFESCAN, a Johnson & Johnson Company, Milpitas, CA 95035, USA, Lot: E-169380A, Exp: 2003-01.

    FDA Recall
    Terminated ·Product code JJQ·October 8, 2002

    Bloom DTU-215-B Programmable Stimulator

    FDA Recall
    Terminated ·Fischer Imaging Corporation·Product code JOQ·January 13, 2005

    Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JJQ·July 25, 2016

    BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJQ·February 15, 2005