15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GENESIS II TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Scissors, Micro, acc. Potts round-handle 17cm 45° edge 10mm
FDA UDI
Geister Medizintechnik GmbH·04057034007648·Scissors, Micro, acc. Potts
round-...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0360120·Modular Tip, Bifid, Offset, Left
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106120·Trial, 26 x 12mm, 8 Degree, Tapered, Straight
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481475562·
MICROSPEED EC MOTORSYSTEM GD650/GD653
FDA 510(k)
FDA Class 2
·Neurology
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
FRIALIT PLUS IMPLANT
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·March 21, 2013
CLUSTER-HOLE POROUS SHELL
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·March 18, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·April 16, 2008
NI
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 6, 2017
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013