12 results · 22ms · Sources: EU EUDAMED, US FDA

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si-Mochi

FDA 510(k)
FDA Class 2 ·Orthopedic

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·January 26, 2016

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 23, 2020

BIOKNOTLESS ANCHOR

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

SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

RECON TARGETING ARM

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code LXH·August 11, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 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