11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PLASMAPOOLER
FDA 510(k)
FDA Class 2
·Hematology
Precept
FDA UDI
Nuvasive, Inc.·00887517350381·PRECEPT Screwdriver, Spring Loaded
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117552·Kelman-McPherson Fcps, 1x2 .12mm, Ang.
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209129089·
MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
APOLLO MINI IPL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SELECTOR 24KHZ NEURO SHORT HANDPIECE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, LTD.·Product code LFL·June 4, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·Product code OYC·May 8, 2014
23 CM STRAIGHT HEMOSPLIT STANDARD KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·October 17, 2012
PFC SIGMA CRVD INS SZ4 12.5MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 11, 2010
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