19 results · 21ms · Sources: EU EUDAMED, US FDA

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EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557273·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557228·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557259·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557266·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557280·

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0140040·Driver Shaft, T30 Split Tip Double End Cap Starter

InTess C Cervical Cage System

FDA UDI
Kalitec Direct LLC·B07309K01405N0·Cervical Rasp, 15 x 12, 5mm, 0 Degree, No Taper

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557297·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033557242·

GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

THE ALBERTA LENS SM2, SULFOCON B

FDA 510(k)
FDA Class 2 ·Ophthalmic

BD VACUTAINER SERUM BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·April 27, 2021

OT VERIO TEST STRIPS

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

ACCENT DR RF

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

9617604-2008-00055

FDA Adverse Event
Death ·Product code FPA·March 12, 2008

ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·June 4, 2014

WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

FDA Enforcement
Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

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