18 results · 22ms · Sources: EU EUDAMED, US FDA

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BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

VARICES INJECTION NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

FDA 510(k)
FDA Class 2 ·Hematology

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTL.·Product code MNI·September 16, 2011

APASS LP

FDA Adverse Event
Other ·MEDICREA INTERNATIONAL·Product code MNI·June 15, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP

FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 29, 2013

SYNERGY

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 4, 2011

PROGR. VALVE

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·July 28, 2008

PASS LP

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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