17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COOK FIVE LUMEN CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032274·Baltic Denture System BDLoad Lw6 PLSEbil2DFl B2...
Mini Tweed
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746160158·DB BKT MINI TWEED UNIV CUSP 022 T=0 A=0 R=0 MMS...
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
FDA 510(k)
FDA Class 2
·Cardiovascular
BOM 7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GCJ·March 27, 2019
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 29, 2011
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·April 21, 2008
PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD
FDA Adverse Event
Injury
·COVIDIEN·Product code FGE·November 30, 2020
VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code NIO·November 30, 2020
PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
FDA Adverse Event
Injury
·COVIDIEN·Product code FGE·November 30, 2020
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016