10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE CONNECTORS
FDA 510(k)
FDA Class 1
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707056584·DB TUBE MIM 22/51 OCC RIGHT
ACUMED
FDA UDI
Acumed LLC·10806378100109·ARH Slide-Loc™ Locking Guide +1 mm
REUSABLE CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
FDA 510(k)
FDA Class 2
·Cardiovascular
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·May 9, 2014
54 CM BIPOLAR LEAD
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL·Product code DTB·October 19, 2012
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·May 28, 2015
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
FDA Enforcement
Class II
·Terminated·Acumed LLC·June 7, 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