11 results
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21ms
·
Sources: EU EUDAMED, US FDA
MEDSURG STERILE O.R. TOWELS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VARIAX
FDA UDI
Stryker GmbH·07613327126105·Labeling Clip
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117452·Modular Knee Stem Pilot 17mm x 150mm
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203535·Interbody, 9mm x 40mm x 17mm, 15 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195540·Interbody, 9mm x 40mm x 17mm, 15 deg
INTRAVASCULAR ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
FDA 510(k)
FDA Class 2
·Orthopedic
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·December 23, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·March 21, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020