14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MANAN BONE MARROW HARVEST NEEDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SIGMA
FDA UDI
DEPUY (IRELAND)·10603295223498·SIGMA FEMORAL CRUCIATE RETAINING POROCOAT SIZE ...
Bioseal Inc.
FDA UDI
BIOSEAL·00630094194004·Baby Blanket White w/Stripes
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989006940·ID R - Twin - Lower-Universal Anterior - Red
George King Multi-Coumadin® Kit
FDA UDI
GEORGE KING BIO-MEDICAL, INC·00815696020719·George King Multi-Coumadin® Kit is citrated fre...
ACS POLY W/ LIP 28 GR2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 16, 1999
NA
FDA UDI
STRYKER CORPORATION·07613327115116·2.5 inch (63.5mm) Stainless Steel Cast Cutter B...
A1C-CELLULAR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
STAINLESS STEEL BLADE
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code LGH·November 7, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 29, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 1, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 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