11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
FDA 510(k)
FDA Class 2
·Orthopedic
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122155·KWire .028x4" (0.7x100mm)
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197028691·Iris Scissors
curved...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 22, 2025
METHAFILCON A
FDA 510(k)
FDA Class 2
·Ophthalmic
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013
REBUILDER
FDA Adverse Event
Injury
·REBUILDER MEDICAL TECHNOLOGY INC·Product code GZJ·July 8, 2008
ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code KOG·April 27, 2011
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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