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

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POWERCROSS .018 OTW PTA DILATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA

FDA 510(k)
FDA Class 1 ·General Hospital

SYMPHONY GRAFT DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

56MM AND R3 ACETABULAR SHELL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 6, 2013

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 16, 2014

ZIMMER NATURAL NAIL TIBIAL NAIL

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HSB·May 3, 2011

SORIN AF 620 W/LOOP 10

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWE·June 25, 2010

C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016

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

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012