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

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CRYO Arctic, CRYO Penguin

FDA 510(k)
FDA Unclassified ·Unknown

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668101162·DLEK CORNEAL DISSECTOR, VAULTED

FLEXCERA BASE

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

SOCRATES ROBOTIC TELEMONITORING SYSTEM

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

LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

TITAN SCROTAL ZERO ANG 20CM

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FHW·July 18, 2018

UNKNOWN_KIE_PRODUCT

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·October 27, 2014

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

OT ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2013

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