19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496022480·FITNESS, SIZE XXL, NERO, GRADUATED COMPRESSION ...
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 48cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014440·
Instant-View HCG Midstream Cassette
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·00796918000019·HCG Midstream Cassette
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981173791·Closed, Axial Rod, Long, 480mm
Instant-View HCG Midstream Cassette, 2t
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918002140·HCG Midstream Cassette, 2 tests
RBM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VANGUARD REPROCESSED INFLATION DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
VICKS
FDA Adverse Event
Other
·KAZ, INC.·Product code KFZ·March 15, 2013
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·February 15, 2011
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·March 31, 2008
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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