14 results · 30ms · Sources: EU EUDAMED, US FDA

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ENDOMARK STERILE INDIA INK

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

Phonak

FDA UDI
Sonova AG·07613275614228·Phonak Naída B50-R RIC (beige)

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981187651·Left Tip, Wide

COLOR-MONOGEN

FDA 510(k)
FDA Class 2 ·Immunology

KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

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

BD ULTRA-FINE INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 11, 2019

ACCURUS 800CS

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 5, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

CONTAK RENEWAL 3 RF

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

M2A 38MM ONE PIECE CUP SZ 50MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 5, 2015

M2A 38MM MOD HEAD -3MM NK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·November 5, 2015

VIDAS® CA 15-3 ASSAY

FDA Adverse Event
Injury ·BIOMERIEUX, SA·Product code LTK·March 8, 2018

A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

FDA Enforcement
Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

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