17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Weropress Polymer C34 no veins
FDA UDI
Merz Dental GmbH·D7091020069·Weropress Polymer C34 no veins, 1000g
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717100482·Sponges 2" x 2" 4 ply Non-woven, Non Sterile Ca...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036019020·
NA
FDA UDI
STRYKER CORPORATION·04546540755711·8MM CORE DRILL TIBIAL
ROSA® PPK
FDA UDI
Zimmer, Inc.·00889024619395·
ROSA® PPK
FDA UDI
Zimmer, Inc.·00889024619388·
ROSA®
FDA UDI
Zimmer, Inc.·00889024619401·
ASCEND SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DURABOND NON-PRECIOUS CERAMIC ALLOY
FDA 510(k)
FDA Class 2
·Dental
SPIRIT MB
FDA Adverse Event
Malfunction
·ORMCO CORPORATION·Product code DYW·March 14, 2014
1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·November 2, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007
FEMORAL NAIL, A/R S2 Ø11X400 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·March 25, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 9, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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