16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AltiVate® Anatomic Pegged Glenoid with Markers
FDA 510(k)
FDA Class 2
·Orthopedic
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM
XLP - CPRotector® Deluxe - Orange Nylon Pouch
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030067·XLP - CPRotector® Deluxe - Orange Nylon Pouch
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A203026120·20mm H x 30mm W x 26mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A20302680·20mm H x 30mm W x 26mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A203026150·20mm H x 30mm W x 26mm L x 12 degrees ALIF
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 18, 2020
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 11, 2020
PFC SIGMA LUGGED TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
ELECTRO SENSOR -BODY COMPOSITION
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MAX SYSTEM, BD MAX INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 3, 2020
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC·Product code LOX·October 17, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012