12 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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PARA TECH FOR TECHNICON H-1
FDA 510(k)
FDA Class 2
·Hematology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149830·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.5mm DIA...
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
FDA 510(k)
FDA Class 2
·Microbiology
QUALA DENTAL PRODUCTS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011
ACE
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 13, 2014
IDENTITY DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
FDA Adverse Event
Injury
·STRYKER ORTHPAEDICS MAHWAH·Product code MEH·December 27, 2012
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021