35 results
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45ms
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Sources: EU EUDAMED, US FDA
Regulora®
FDA UDI
Metame Health, Inc.·00860005970209·Regulora® is prescription-only digital therapeu...
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
FDA Recall
Terminated
·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code FNL·July 21, 2014
LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.
FDA Recall
Terminated
·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code LLI·April 17, 2012
Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
FDA Recall
Terminated
·Anchor Products Company, Inc.·Product code GCJ·December 9, 2010
Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
FDA Recall
Terminated
·Anchor Products Company, Inc.·Product code GCJ·December 9, 2010
CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
FDA Recall
Terminated
·Trophy Sas 4 Rue Pelloutier Croissy Beaubourg France·Product code EAP·September 18, 2012
CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
FDA Recall
Terminated
·Trophy Sas 4 Rue Pelloutier Croissy Beaubourg France·Product code EAP·September 18, 2012
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
FDA Recall
Terminated
·Trophy Sas 4 Rue Pelloutier Croissy Beaubourg France·Product code EAP·September 18, 2012
CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
FDA Recall
Terminated
·Trophy Sas 4 Rue Pelloutier Croissy Beaubourg France·Product code EAP·September 18, 2012
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
FDA Recall
Open, Classified
·Angiodynamics, Inc.·Product code MSD·March 18, 2024