14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DEN-MAT DENTIN BONDING AGENT
FDA 510(k)
FDA Class 2
·Dental
Precept
FDA UDI
Nuvasive, Inc.·00887517350367·PRECEPT Screwdriver, Short
Total Foot System 2
FDA UDI
Smith & Nephew, Inc.·00885556837986·FOREFOOT UNIVERSAL PLATE. 16MM
Integra® Total Foot System
FDA UDI
Ascension Orthopedics, Inc.·10381780119388·The Integra Total Foot System Universal Forefoo...
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58208012160·IMPACTOR
NAR kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209121991·KIT, NAR RESPONDER BALLISTIC VEST SYSTEM - RED
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
AUDIT MICROCV PROTEIN LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD PERFUSION¿ SYRINGE W/NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·May 18, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014
OTW,XK,23CM, ST, SPLIT TIP, STANDARD KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·October 17, 2012
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 16, 2010
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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