15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULAR TROCAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00600961·
Reagent Kit
FDA UDI
Chromsystems Instruments + Chemicals GmbH·04250317537492·MassChrom® Biogenic Amines/Metabolites in urine...
MULTI CARE THERAPEUTIC VIBRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 5, 2013
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2008
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
11.0MM/8.0MM PROTECTION SLEEVE153MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code FZX·April 15, 2013
INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code FZX·April 15, 2013
8.0MM/4.0MM DRILL SLEEVE 164MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code FZX·April 15, 2013
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code FZX·April 15, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024