BEUDAMED
    51 results · 16ms · Sources: EU EUDAMED, US FDA

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    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code JLX·September 13, 2024

    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OHM·March 22, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code LRO·March 22, 2023

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CAI·May 18, 2023

    Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

    FDA Recall
    Open, Classified ·Product code LRO·May 28, 2026

    React Health PHOENIX 5L Oxygen Concentrator

    FDA Recall
    Open, Classified ·3B Medical, Inc. 5475 Rings Rd Ste 550 Dublin OH 43017-7537·Product code CAW·February 4, 2026

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CAI·May 15, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OJH·March 22, 2023

    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    FDA Recall
    Open, Classified ·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021

    Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

    FDA Recall
    Open, Classified ·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021

    Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

    FDA Recall
    Open, Classified ·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021

    Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

    FDA Recall
    Open, Classified ·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021

    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OJG·March 22, 2023

    HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

    FDA Recall
    Open, Classified ·Hitachi Healthcare Americas Corporation·Product code IYN·June 30, 2021

    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

    FDA Recall
    Open, Classified ·Applied Medical Technology Inc·Product code PIF·November 26, 2024