14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B-Laser Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Boss Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515235335·Rhoton Style Bay Bipolar Fcp, .7 tip, 10 1/4", ...
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 18x16x4x2
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015828·For patients requiring hip positioning that are...
NYOrtho APEX CORE Wedge Wheelchair Cushion Gel-Foam 18x16x4x2
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677011851·For patients that are inclined to slide forward...
NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Foam 18x16x4x2
FDA UDI
N.Y. ORTHOPEDIC USA, INC.·00811677015903·For patients requiring hip positioning that are...
WIZARD 230 NASAL PILOW MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ONCO TRAC MODEL 1, 2, 4
FDA 510(k)
FDA Class 2
·Radiology
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 12, 2025
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·June 14, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·September 29, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018