15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PHILIPS THORAVISION
FDA 510(k)
FDA Class 2
·Radiology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981657·anteriors; shade D3 light; mould BS2
POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AIRVANCE BONE SCREW (REPOSE) SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRK·March 3, 2014
AIRVANCE BONE SCREW (REPOSE) SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code LRK·March 29, 2013
OT ULTRA TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 27, 2013
OMNIFIT AXIAL REAMER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·January 12, 2011
COMP PRIMARY STEM 7MM MINI
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·August 5, 2014
AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRK·November 30, 2015
AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code LRK·October 2, 2015
BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019
BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019
BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 31, 2019
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