13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517962423·Brigade Lateral Trial, 9x34x32mm 8°
Gravity Compensating Accessory
FDA UDI
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033516·The Gravity Compensating Accessory (GCA) is des...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515229334·McCabe Facial Nerve Diss ang 14mm smooth jaw, 5...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515307964·McCabe Facial Nerve Dissector ang smooth jaw, 7...
IRRIGATION AND SUCTION APPARATUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 30, 2014
MALLINCKRODIT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO HEALTH, AVENIDA HENEQUEN·Product code BTR·January 2, 2013
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code MQR·November 19, 2010
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 2023
XP-CR Tibial Tray - Interlok 87 mm Item # 195278
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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