BEUDAMED
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    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HWE·March 25, 2015

    Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098 OB-Windows provides professional reporting and analysis of fetal growth throughout the gestational period, which can help evaluate clinical situations. OB-View provides image management for the user to capture, view, read, and edit images.

    FDA Recall
    Terminated ·Digisonics, Inc·Product code LLZ·February 9, 2007

    Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FRJ·January 20, 2016

    Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Omnipod 5 Automated Insulin Delivery System

    FDA Recall
    Open, Classified ·Product code QFG·February 28, 2023

    Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code MSS·August 18, 2003

    Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

    FDA Recall
    Open, Classified ·NuVasive Inc·Product code OLO·July 19, 2022

    Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.

    FDA Recall
    Terminated ·Acumedia Manufacturers, Inc.·Product code JSK·September 11, 2015

    MD4 X-ray system

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·April 6, 2006

    MD3 X-ray system

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·April 6, 2006

    Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle

    FDA Recall
    Terminated ·C P Medical Inc.·Product code NEW·April 23, 2014

    Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code LMD·December 11, 2009

    ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

    FDA Recall
    Terminated ·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)·Product code EXY·April 21, 2022

    Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·July 25, 2008

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code GCJ·June 7, 2022

    Misys Laboratory with Lab Access Results application for versions 5.3 and later.

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·May 13, 2005

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code GCJ·June 7, 2022