19 results · 29ms · Sources: EU EUDAMED, US FDA

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Temno Elite Biopsy System

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

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433866·Integra® Jarit® Kelly Retractor, 10", Hollow Gr...

24M - Nevada Energy - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113998·HYDRO-DISSECT CANNULA VERTICAL 27GA

LIPOSUCTION CANNULA

FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011660·LIPOSUCTION CANNULA COBRA

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450156537·

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR

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

ULTRA V THERAPEUTIC ULTRASOUND

FDA 510(k)
FDA Class 2 ·Physical Medicine

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·August 10, 2015

BD ANGIOCATH¿ PLUS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·October 2, 2018

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·January 21, 2016

ALARIS® PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION·Product code FPA·April 17, 2017

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

ALARIS

FDA Adverse Event
Malfunction ·CAREFUSION·Product code FPA·April 8, 2013

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021