23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LITECURE THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ACETABULAR LINER H-WALL 28MM ID SZ B
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·August 9, 2017
ARGEDENT 54
FDA UDI
ARGEN CORPORATION, THE·D818103511·Gold based noble metal
IgM RID plate kit
FDA UDI
KENT LABORATORIES INC·B1761035·Radial immunodiffusion plate package for human ...
Ti-one 101
FDA UDI
HUNG CHUN BIO-S CO., LTD.·04719871590034·Dental Implant Ø3.5, 11 mm Length
The Ti-one 10...
Paragon 28
FDA UDI
Provision·B504OMP9911035110·
Monster® Screw System
FDA UDI
Paragon 28, Inc.·00889795040664·Over Drill, 3.5 x 110mm, Cannulated, AO
MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511
FDA 510(k)
FDA Class 1
·Hematology
KENDALL-LTP TURNER SAVE-A-LINE
FDA 510(k)
FDA Class 1
·General Hospital
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVEA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 17, 2015
28MM DIA TI MOD HEAD ION STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZY·August 9, 2017
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INCORPORATED·Product code HSB·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 19, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 26, 2011
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·August 8, 2025
Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013
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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021