13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XORANCONNECT
FDA 510(k)
FDA Class 2
·Radiology
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2021
MINIME NASAL MASK, MODEL P/N 50220
FDA 510(k)
FDA Class 2
·Anesthesiology
C. DIFFICILE TOX A/B II
FDA 510(k)
FDA Class 1
·Microbiology
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 23, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 1, 2011
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 22, 2020
NORIAN DRILLABLE INJECT 10CC-STERILE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQV·February 7, 2018
Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680
FDA Recall
Terminated
·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006
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