BEUDAMED
    130 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010

    FDA Recall
    Terminated ·Perkinelmer·November 26, 2012

    Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.

    FDA Recall
    Terminated ·Perkinelmer·November 26, 2012

    NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

    FDA Recall
    Terminated ·Perkinelmer·Product code JLA·November 26, 2012

    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

    FDA Recall
    Terminated ·Perkinelmer·Product code NQL·November 26, 2012

    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.

    FDA Recall
    Terminated ·Perkinelmer·Product code JNB·November 26, 2012

    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code JIN·March 8, 2022

    Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·March 25, 2015

    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·March 25, 2015

    GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

    FDA Recall
    Terminated ·Generic Medical Devices·Product code FTL·June 18, 2009

    NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-1 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-1 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-1- Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-2, 5082-104-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113 and 30502-213 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-2 and 636-5084-104-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - firm on label is Welch Allyn, Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #30502-110S, firm on label is Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #5084-101-1, firm on label is Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111 and 30502-211 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-2 and 634-5084-102-2 - Arden, Skaneateles, NY.

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXQ·March 1, 2004

    Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FNL·October 7, 2015