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

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SPACER-S TEMPORARY SHOULDER SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051931·Symmetry® Forceps, Tissue, 1 x 2 Teeth, 14 in

Baby Gorilla/Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795021298·Baby Gorilla, Plate, DUB-Y 5-3-5, 13 Hole Locki...

TRIFIX SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

QUANTA LITE LKM-1 ELISA

FDA 510(k)
FDA Class 2 ·Immunology

XMAX MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·April 10, 2013

J-VAC RESERVOIR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code GCY·June 12, 2008

MODULAR CATHCART BALL 43MM OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LZY·April 6, 2011

UNKNOWN BEARING

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017

enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

FDA Enforcement
Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026