13 results
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22ms
·
Sources: EU EUDAMED, US FDA
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450243169·
PERFORM. C/R TIB. BEAR.
FDA Adverse Event
Injury
·KIRSCHNER/BIOMET, INC.·Product code JWH·July 11, 2002
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC. SAN ANGELO·Product code GAM·April 14, 2000
UNIFY ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
SELOX JT 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·May 3, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 18, 2011
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·November 7, 2013
DISTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 8, 2019
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code HXX·June 5, 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