13 results · 20ms · Sources: EU EUDAMED, US FDA

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DNA/RNA Shield Collection Tube

FDA 510(k)
FDA Class 2 ·Microbiology

Cal OSHA - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal

Sklar®

FDA UDI
SKLAR CORPORATION·10649111166587·KILNER NEEDLE HOLDER 6 1/2"

FLEXCERA BASE

FDA Adverse Event
Malfunction ·ENVISIONTEC GMBH·Product code EBI·November 10, 2021

TOKUYAMA REBASE II

FDA 510(k)
FDA Class 2 ·Dental

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE

FDA 510(k)
FDA Class 2 ·Dental

BARRIGEL INJECTABLE GEL

FDA Adverse Event
Malfunction ·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024

HEARTSTART ONSITE

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·August 5, 2011

OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

FDA Adverse Event
Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING·Product code FJI·September 18, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

SILIC FOLEY CATH 5/10ML /5

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code EZL·February 15, 2019

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 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