14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00722121·
PMMA disc
FDA UDI
Dentsply International Inc.·D00180722120·
Channel Drain
FDA UDI
C. R. Bard, Inc.·00801741049774·Channel Drain, 7mm Flat Full Fluted with 4.7mm ...
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540337955·DELTA DRILL 2.2MM F.8/10MM SCREW,STRYKER
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021665·
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
FDA 510(k)
FDA Class 2
·Cardiovascular
Crescendo Meniscal Insert CR Ultracongruent 12mm Size 2
FDA UDI
AMPLITUDE SAS·03701089524742·
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
ACCESS® IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·April 28, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
CHANNEL DRAIN
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·November 21, 2024
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