12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PARADIGM 1.5ML RESERVOIR, MODEL 326
FDA 510(k)
FDA Class 2
·General Hospital
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code HWC·July 8, 2015
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code HWC·July 8, 2015
DRIVER SHAFT, T-15, MEDIUM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·August 7, 2025
SYNFIX - LR 26MM DEPTH/32MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MAX·February 11, 2013
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO INC.·Product code GJS·February 16, 2011
JOURNEY
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION·Product code HSH·February 25, 2008
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
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