10 results · 19ms · Sources: EU EUDAMED, US FDA

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TOUCHLESS CLEAN-CATH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776124083·Bayonet Bipolar Forceps, angled up

Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120

FDA 510(k)
FDA Class 2 ·Cardiovascular

UNIVERSAL AO REAMER ATTACHMENT 350 RPM

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL S.A.·Product code GEY·February 25, 2014

REPLY

FDA Adverse Event
Malfunction ·SORIN CRM S.R.L.·Product code NVZ·October 19, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 18, 2007

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015