BEUDAMED
    85 results · 35ms · Sources: EU EUDAMED, US FDA

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    Filters Status: Terminated ×

    Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193; d) RP-M Series Ultrafine Filters 6 pack model number 1029331; e) RP Vision OM Reg Filter (ASCO) model number 1007547; and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system

    FDA Recall
    Terminated ·Epocal Inc·Product code CGA·June 28, 2011

    Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code GWQ·October 15, 2007

    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.

    FDA Recall
    Terminated ·EM Innovations Inc·Product code MMK·April 3, 2006

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT220 2.3mm (D) x 20.0 mm (L) STERILE.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

    ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.

    FDA Recall
    Terminated ·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Recall
    Terminated ·Pharmaceutical Innovations, Inc.·Product code MUI·August 13, 2020

    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DDK315 LOT Disposable Drill Kit with DT315 STERILE

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

    Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.

    FDA Recall
    Terminated ·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019

    Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZE·May 9, 2003

    Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps

    FDA Recall
    Terminated ·2k Innovations Inc.·Product code IRT·April 15, 2016

    Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZE·May 9, 2003

    WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.

    FDA Recall
    Terminated ·Innovative Neurotronics, Inc.·Product code GZI·August 6, 2008

    EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

    FDA Recall
    Terminated ·Implant Innovations, Inc.·Product code DZE·October 4, 2004

    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.

    FDA Recall
    Terminated ·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019

    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.

    FDA Recall
    Terminated ·Data Innovations, Inc.·Product code JQP·May 11, 2009