13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERCUTANEOUS INTRODUCERS
FDA 510(k)
FDA Class 2
·Cardiovascular
Brigade
FDA UDI
Nuvasive, Inc.·00887517963413·Brigade Lateral Trial, 10x38x28mm 20°
ReLine
FDA UDI
Nuvasive, Inc.·00195377068613·RELINE C Screw, 3.5x30mm MA
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014520·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515229655·Paparella Tissue Press
Albumin BCP2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPIRODOC
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 30, 2014
SPEEDBAND SUPERVIEW SUPER 7¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·January 9, 2013
FLEXOR ANSEL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·November 19, 2010
Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024