16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Qraycam PRO
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Mueller Hinton II Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902212758·BD BBL™ Mueller Hinton II Agar (100 x 15 mm sty...
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024400597·
Lightera, LLC
FDA registration
Lightera, LLC·2 products·🇺🇸 United States
Life Instruments
FDA UDI
Life Instrument Corporation·M930722127500·Custom Micro Cobb 8" WL, 4.63" Handle
MICOMED POSTERIOR DOUBLEROD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
FDA 510(k)
FDA Unclassified
·Unknown
CAPTURE-R READY-ID EXTEND I
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·March 19, 2019
ALALRIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·March 3, 2017
GLENOSPHERE ORIENTATION GUIDE
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·February 12, 2016
V40 COCR LFIT HEAD 36MM/+5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·August 17, 2011
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·November 3, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
FDA Enforcement
Class II
·Ongoing·Labories Medical Technologies·May 10, 2023
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021