11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Compex Sport Elite 3.0
FDA 510(k)
FDA Class 2
·Physical Medicine
Mini-Taurus
FDA UDI
Rmo, Inc.·00885797100733·ALEX MT 022 HK/2,3 5-5 20EA
SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025
CODMAN BACTISEAL EVD CATHETER SET
FDA 510(k)
FDA Class 2
·Neurology
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
FDA 510(k)
FDA Class 2
·Orthopedic
HAMILTON-C6
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025
NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·July 10, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
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