13 results · 38ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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