11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
NOBELREPLACE CC PMC RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
PARE ENDOSCOPIC SUTURING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2024
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·April 23, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 13, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
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