20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Precice® Bone Transport System
FDA 510(k)
FDA Class 2
·Orthopedic
EarQ
FDA UDI
Oticon A/S·05707131353337·G40 S, MINIRITE 312 2.4G C044 EARQ
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANTAGE THC TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNKNOWN SCS SYSTEM
FDA Adverse Event
Malfunction
·UNKNOWN·Product code LGW·August 12, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
ABS 2000
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·February 28, 2008
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·June 26, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
2250051-2008-00372
FDA Adverse Event
Malfunction
·Product code JTC·July 24, 2008
UNKNOWN GASTROJEJUNAL FEEDING TUBE
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018
UNKNOWN GASTROJEJUNAL FEEDING TUBE
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018
UNKNOWN GASTROJEJUNAL FEEDING TUBE
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018
UNKNOWN GASTROJEJUNAL FEEDING TUBE
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 14, 2023
BIOLOX DELTA CER HEAD 28 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·January 21, 2016
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·April 4, 2018
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class II
·Terminated·GE Healthcare·February 12, 2014
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021