13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETEST MOXIFLOXACIN 0.002-32 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
LEONE SPA
FDA UDI
LEONE SPA·08033707065852·EXTRAORAL ELASTICS 1/2" 8 oz
LEONE SPA
FDA UDI
LEONE SPA·08033707065685·INTRAORAL ELASTICS 4,5 oz 1/8" brown
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ADAPTERS WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 18, 2026
AISYS
FDA Adverse Event
Injury
·DATEX-OHMEDA·Product code BSZ·May 1, 2013
CONSERVE(R) TOTAL HEAD W/BFH
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·September 16, 2014
ENT PLASMA WAND
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·April 15, 2011
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)
FDA Recall
Terminated
·Surgical Specialties Corp·Product code GAT·August 25, 2003
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