BEUDAMED
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    NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·November 29, 2017

    NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

    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

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

    FDA Enforcement
    Class II ·Terminated·Cook Medical Incorporated·February 3, 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

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    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

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

    Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·December 28, 2016

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

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 19, 2014

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    FDA Enforcement
    Class II ·Terminated·Ossur North America Inc·November 27, 2013

    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·October 26, 2016

    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.

    FDA Enforcement
    Class II ·Terminated·Orthosensor·October 31, 2012

    Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing intended to to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 6, 2008