11 results
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18ms
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Sources: EU EUDAMED, US FDA
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