12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESPONSE Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133494·LATERAL,0 DEGREE LORDOSIS
WIZAIR COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DIFFUSION TENSOR IMAGING OPTION
FDA 510(k)
FDA Class 2
·Radiology
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 9, 2021
GROSHONG CATHETER
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code DQO·October 16, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2013
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·October 3, 2024
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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