19 results · 21ms · Sources: EU EUDAMED, 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