17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CATHETER, NASAL, OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517175670·VuePoint Screw, 4x20mm Fav Angle Tulip
Anti-nDNA IgG IFA 96 Test
FDA UDI
Hemagen Diagnostics, Inc.·G5229024201·For the detection and titration of anti-native ...
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080369·INSERTER 902-420 20MM OPEN ANT BD
HITACHI ALTAIRE
FDA 510(k)
FDA Class 2
·Radiology
KRD1 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
3.0 x 34CM HI-RES GALILEAN LOUPE - 902420
Device
EU MDR
·
Eu Md Class 1
·Keeler Ltd·On the market·1 country
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·December 5, 2024
INTEGRAL/X POR RED PROX 13MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 18, 2019
ROTICULATOR ENDO GRASP* 5MM W/SPIN LOCK
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GET·July 9, 2015
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 9, 2009
SELEX/MAGNUM MOD HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·October 24, 2018
FEMORAL MODULAR HEAD - S Ø28MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·April 13, 2023
PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 2, 2019
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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