10 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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MICROALBUMIN REAGENT SET AND CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
AUTO SUTURE SURGICAL STAPLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M3 (MICRO-MULTILEAF COLLIMATOR)
FDA 510(k)
FDA Class 2
·Radiology
PEDICLE SCREW 03.58.264 MUST MC SCREW Ø7X40 CANNULATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·April 12, 2024
SECUR-FIT MAX 127 HIP STEM #7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·March 27, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 14, 2011
SYNVISC (HYLAN G-F 20) INJECTION 2ML
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 2, 2008
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 16, 2017
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
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024