102 results
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17ms
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Sources: EU EUDAMED, US FDA
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Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L
FDA Recall
Open, Classified
·NuVasive Inc·Product code MJO·June 20, 2022
Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Recall
Open, Classified
·Linet Americas·Product code HDD·March 6, 2020
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMD·January 3, 2022
Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4469A The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.
FDA Recall
Terminated
·Product code HGD·February 7, 2012
AVE 2 Birthing Bed
FDA Recall
Terminated
·Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic·Product code HDD·January 7, 2019
Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·November 16, 2009
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMD·March 30, 2018
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code HGD·April 8, 2024
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMD·December 27, 2016
Stryker brand Birthing Bed; Model 4701.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·March 31, 2005
Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·September 6, 2007
Stryker brand Adel maternity bed, model 4700, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
FDA Recall
Terminated
·Amd-Ritmed, Inc.·Product code FQM·March 30, 2016
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
FDA Recall
Terminated
·AMD Medicom Inc.·Product code FXX·October 11, 2019
Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles
FDA Recall
Terminated
·EMD Chemicals Inc·Product code KQC·July 30, 2007
Picasso/Picasso Lite lasers Intended use: Dentistry.
FDA Recall
Terminated
·AMD Lasers, LLC·Product code GEX·April 15, 2010
Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.
FDA Recall
Terminated
·EMD Chemicals Inc.·Product code KQC·April 4, 2011
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
FDA Recall
Terminated
·EMD Chemicals Inc·Product code J·August 17, 2006