18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo Application Software
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103562·7.0 x 80mm Cannulated Screw, 16mm Thd
OsteoMed
FDA UDI
OSTEOMED LLC·00842528107928·7.0 x 80mm Cann Screw 16Thd Sterile 2Pk
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE
FDA 510(k)
FDA Unclassified
·Unknown
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 7, 2008
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 14, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·April 11, 2016
"2.4MM" SYSTEM HIGH TORQUE (HT)CROSS-DRIVE SCREW (2.7 X 10MM TITANIUM)
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·February 7, 2018
TMJ SYSTEM LEFT FOSSA COMPONENT SMALL
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 7, 2018
TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 7, 2018
TMJ SYSTEM CROSS DRIVE FOSSA SCREW (2.0MM X 11MM)
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·February 7, 2018
TMJ SYSTEM CROSS DRIVE FOSSA SCREW (2.0MM X 9MM)
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·February 7, 2018
"2.4MM" SYSTEM HIGH TORQUE (HT)CROSS-DRIVE SCREW (2.7 X 8MM TITANIUM)
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·February 7, 2018
TMJ SYSTEM CROSS DRIVE FOSSA SCREW (2.0MM X 7MM)
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·February 7, 2018
TMJ SYSTEM RIGHT FOSSA COMPONENT SMALL
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 7, 2018
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014