15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256620·
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868308314·
SAPPHIRE ST PORTABLE DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE S2 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 22, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH
FDA Adverse Event
Other
·GYRUS ACMI, INC.·Product code FDC·June 13, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·September 9, 2008
BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 22, 2023
DISCARDIT II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 20, 2019
BD DISCARDIT II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 1, 2019
BD DISCARDIT II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 7, 2019
VORTEX
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC.·Product code LJT·March 2, 2026
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015