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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PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180502976·Distractor Tip, Lamina, Long, No Offset, Right
O-PERM 30
FDA 510(k)
FDA Class 2
·Ophthalmic
CLEARFIL CORE NEW BOND
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
MERSILENE POLYESTER FIBER MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 23, 2013
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·April 29, 2011
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·July 10, 2008
ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code JWM·February 10, 2003
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
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