14 results
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18ms
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Sources: EU EUDAMED, US FDA
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
FDA 510(k)
FDA Class 2
·Immunology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023185·The ENDO CARRY-ON Procedure Kit contains all of...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003239·DeBakey Needle Holder Diamond Dust™ Jaw
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134140·Trial, TLIF, 27L OB STR 7Deg, 14mm
KWIKKMODEL
FDA 510(k)
FDA Class 2
·Dental
MEDISUL DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LOW PROFILE PELVIC SYSTEM RED
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·February 28, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 1, 2011
EXPRESS VASCULAR SD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIN·February 21, 2008
TECNIS ODYSSEY IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code MFK·January 7, 2026
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·May 3, 2017
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024