13 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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MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517961723·Brigade Lateral Trial, 10x34x24mm 30°
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118092960·DIST, LEFORT 3/MONO, GORDON, 1.5-1.8 MM SCREW, ...
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118092984·PLATE, LEFORT 3/MONO, GORDON, CVD, RIGHT, FOR 9...
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118092977·PLATE, LEFORT 3/MONO, GORDON, CVD, LEFT, FOR 99...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973530·
COLOSCREEN-ES
FDA 510(k)
FDA Class 2
·Hematology
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133
FDA 510(k)
FDA Class 2
·Cardiovascular
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012
CERAMIC OPTION TYPE 1 TAPER SLEEVE -3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·June 30, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 9, 2013
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KXA·November 16, 2010
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