BEUDAMED
    246 results · 14ms · Sources: EU EUDAMED, US FDA

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    HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.

    FDA Recall
    Terminated ·Embeem Inc.·Product code NAE·November 9, 2006

    Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

    FDA Recall
    Terminated ·Safe N Simple, LLC·Product code NAE·August 22, 2018

    VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

    FDA Recall
    Terminated ·CellEra LLC·Product code NAE·September 1, 2016

    Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code NAE·September 30, 2015

    Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

    FDA Recall
    Terminated ·Safe N Simple, LLC·Product code NAE·August 22, 2018

    15776-20 REG ANES W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    15548-20 REG ANES W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Recall
    Terminated ·X-NAV Technologies, LLC·Product code PLV·February 23, 2016

    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Enforcement
    Class II ·Terminated·X-NAV Technologies, LLC·April 20, 2016

    1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and Complete Delivery System kits including: 1) Item Number CDS980230I, NICU-OR CDS; 2) Item Number DYNJ22691, Basin Supply Pack; 3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit; 4) Item Number DYNJAAHY11, Hyperinflation System-UHS-1L; 5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF; 6) Item Number DYNJAP0011A, Pediatric Circuit-LF; 7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In. CI; 8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF; 9) Item Number DYNJAP0101, Anesthesia Circuit-Ped; 10) Item Number DYNJAP4012, Anesthesia Circuit Ped; 11) Item Number DYNJAP4013, Anesthesia Circuit; 12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line; 13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF; 14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH; 15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF; 16) Item Number DYNJAP4730A, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V; 18) Item Number DYNJAP4740, Anesth Circ 40in Ped; 19) Item Number DYNJAP6101, Anesthesia Circuit; 20) Item Number DYNJAP6105, Anesth Circuit 60in Ped; 21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF; 22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME; 23) Item Number DYNJAP6108, Anesth Circuit 60in Ped; 24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V 1L-LF; 25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW PALL FIL; 26) Item Number DYNJAP6112, Anesthesia-Peds Circuit; 27) Item Number DYNJAP6113, Circuit Pedi 60in; 28) Item Number DYNJAP6114, Anesth Circ 60in Ped; 29) Item Number DYNJAP6116, Anesth Circ 60in Ped; 30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF; 31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL; 32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF; 33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF; 34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia; 35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF; 36) Item Number DYNJAP6136, Circuit Peds Anesthesia; 37) Item Number DYNJAP6137, Circuit Pediatric Anesthesia; 38) Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI; 39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia; 40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF; 41) Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF; 42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp; 43) Item Number DYNJAP7235A, Anesth Circ 72in Ped; 44) Item Number DYNJAP7236A, Anesthesia Pedi 72in; 45) Item Number DYNJAP7237, Circuit Pedi 90in EXP; 46) Item Number DYNJAP7241A, Circuit Pediatric Anesthesia; 47) Item Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree; 48) Item Number DYNJAP7246C, Circuit Pediatric Anesthesia; 49) Item Number DYNJAP7247, Anes Circ Peds 90in Exp; 50) Item Number DYNJAP7248, Anesth Circ Ped 72in Exp; 51) Item Number DYNJAP7261, Circuit Pediatric Anesthesia; 52) Item Number DYNJAP7262, Circuit Pediatric Anesthesia; 53) Item Number DYNJAP7263, Pediatric Anesthesia Circuits; 54) Item Number DYNJAP9005, Anesthesia Circuit; 55) Item Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF; 56) Item Number DYNJAP9725, Pedi Expand Circuit; 57) Item Number DYNJAP9726, Anesth Circ Ped 90in; 58) Item Number DYNJAP9729, Anesth Circ 90in Exp Ped; 59) Item Number DYNJAP9730A, Circuit Pediatric 60in CORR-LF; 60) Item Number DYNJAP9732A, Circuit Pediatric Anesthesia; 61) Item Number DYNJAP9735, Peds Circuit; 62) Item Number DYNJAP9739, Circuit Pediatric Anesthesia; 63) Item Number DYNJAP9740, Circuit Pediatric Anesthesia; 64) Item Number DYNJAP9743, Circuit Pediatric Anesthesia; 65) Item Number DYNJAPF6003, Anesth Circ 60in Ped Unilimb; 66) Item Number DYNJAPF6005A, Anesth Circ 60in Uni Peds; 67) Item Number DYNJAPF6006, Anes Circ Peds 60in Uni; 68) Item Number DYNJAPF6009, Peds Anesthesia Circuit-LF; 69) Item Number DYNJAPF6011, Circuit Pediatric Anesthesia; 70) Item Number DYNJAPF601

    FDA Recall
    Terminated ·Medline Industries Inc·Product code BTC·December 7, 2007

    Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·November 16, 2009

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Lodox Statscan digital radiographic system.

    FDA Recall
    Terminated ·Lodox Na Llc·May 10, 2004

    V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.

    FDA Recall
    Terminated ·Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.·Product code GEH·December 5, 2008

    V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.

    FDA Recall
    Terminated ·Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.·Product code GEH·December 5, 2008

    CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·October 10, 2018

    CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

    Maquet HLM Tubing Pack; Bioline Coating

    FDA Recall
    Terminated ·Maquet Inc.·Product code DWE·July 13, 2010

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 5, 2013

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    FDA Recall
    Terminated ·VGI Medical, LLC·Product code OVD·April 9, 2018