13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROXIMATE ILS CIRCULAR STAPLES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006
CapMedic
FDA 510(k)
FDA Class 2
·Anesthesiology
I-FIX SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PROXIMATE ILS CIRCULAR STAPLERS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006
STANMORE COCR FMRL SZ2 STD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·November 29, 2018
28MM DIA COCR MOD HD +9MM NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 29, 2018
STANMORE COCR FMRL SZ2 STD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·November 30, 2018
28MM DIA COCR MOD HD +9MM NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 30, 2018
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·February 28, 2013
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·February 2, 2011
BACLOFEN PUMP
FDA Adverse Event
Injury
·MEDTRONICS·Product code LKK·August 1, 2014
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