14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033449035·
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
MINITUB MULTI-PURPOSE CASSETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DWC·March 1, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011
SILICONE ADVANCED OPTIC LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·March 13, 2008
DISC HUM 4X100MM RT FLANGED C
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDC·August 15, 2012
DISC CONDYLE KIT W/ HEXALOBULA
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDC·August 15, 2012
DISC ULNA 4X75MM RT W/BRNG C
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·August 15, 2012
RICKHAM RESERVOIR
FDA Adverse Event
Injury
·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015
VENT RES TR RICKHAM LG BA
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 15, 2015
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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025