61 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
FDA Enforcement
Class II
·Terminated·Gyrus Acmi, Incorporated·November 28, 2012
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
FDA Enforcement
Class II
·Terminated·Gyrus Acmi, Incorporated·June 12, 2013
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
FDA Enforcement
Class II
·Ongoing·Gyrus ACMI, Inc.·April 18, 2018
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Olympus Diego Elite Console MDCONS 100
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026
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 Enforcement
Class II
·Terminated·Amd-Ritmed, Inc.·July 27, 2016
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
FDA Enforcement
Class II
·Terminated·Amd-Ritmed, Inc.·December 14, 2016
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
FDA Enforcement
Class II
·Terminated·AMD Medicom Inc.·November 27, 2019
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
FDA Enforcement
Class II
·Terminated·AMD Medicom Inc.·November 27, 2019
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·February 28, 2024