11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Country: United States
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Implant Prosthetics
FDA UDI
Preat Corporation·00842092103135·CAMLOG® Screw-Line-compatible 4.3mm Esthetic Ab...
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023307·The ENDO CARRY-ON Procedure Kit contains all of...
ASPIRE COVERED STENT AND DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
TORQUE LIMITING ATTACHMENT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·February 28, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 1, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 21, 2008
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 15, 2026
CLAV FRAC PLT,CENTRAL THIRD,RT,SS
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·January 27, 2020
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
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