44 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
FDA 510(k)
FDA Class 2
·Microbiology
PureLife X-Ray Film
FDA UDI
Flow X Ray Corporation·00812045030764·PLF-58 Size 2 Single
ReLine
FDA UDI
Nuvasive, Inc.·00195377047458·RELINE-O Trial, 10mm H Offset Left L-pop
Tether
FDA UDI
Seaspine Orthopedics Corporation·10889981101879·Plate Holding Pin
Zavation
FDA UDI
Zavation LLC·00842166131620·Ti3Z CIF 12mmx14mmx6mm -5 deg
Screwdriver
FDA UDI
Treace Medical Concepts, Inc.·00810111225670·2.5MM SCREWDRIVER SUPER 7, CANNULATED
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
FDA UDI
Paonan Biotech Co.,Ltd.·04719878788120·Nerve Retractor 6mm
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869683784·MOSS VRS Tower Shaft
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·January 13, 2006
RITE AID
FDA Adverse Event
Other
·ASO LLC·Product code KGX·August 5, 2013
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code DTB·October 9, 2013
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·June 9, 2016
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·November 23, 2014
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 11, 2011
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021