15 results · 26ms · Sources: EU EUDAMED, US FDA

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Operio

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

LAKONG ULTRASONIC SCALER

FDA 510(k)
FDA Class 2 ·Dental

HYPEROX 101

FDA 510(k)
FDA Class 2 ·Anesthesiology

GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 15, 2020

ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

FDA Adverse Event
Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

STENOSCOP

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·June 21, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

UNIFY ASSURA DR CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

BD ULTRA-FINE¿ INSULIN SYRINGE W STERILE INTERIOR 1ML 0,25MM (31G) X 6MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 22, 2023

ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

FDA Adverse Event
Injury ·CONMED UTICA·Product code GEI·May 18, 2023

ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021