15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 90421 FLEXPORT INTERFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016272·STR, 4 electrode, MPD-CS-S, 2mm electrode spacing
Swish™ Straight Abutment Transfer (2 pieces)
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307121787·
Swish™ Straight Abutment Transfer
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307129936·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515229853·Roller Knife, 3mm ang 90deg to shft
Sklar®
FDA UDI
SKLAR CORPORATION·10649111213274·GRAVES SPEC LG 1 3/8 X 4.5"
REPROCESSED ULTRASONIC COAGULATING SHEARS
FDA 510(k)
FDA Unclassified
·Unknown
Vinyl Examination Gloves (Yellow)
FDA 510(k)
FDA Class 1
·General Hospital
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 20, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 19, 2025
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 19, 2022
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,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024