12 results
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18ms
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Sources: EU EUDAMED, US FDA
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
n/a
FDA UDI
Ortho Development Corporation·00822409074242·10/12 Broach 13x19
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NUVASIVE MASH
FDA 510(k)
FDA Class 2
·Orthopedic
EPD 60000 RPM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 9, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 15, 2011
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZI·September 3, 2013
CABLE 3M TO CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024