13 results
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38ms
·
Sources: EU EUDAMED, US FDA
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
FDA 510(k)
FDA Class 2
·Anesthesiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450522523·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450218839·
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TITAN
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·March 29, 2022
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·May 17, 2011
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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