21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G)
FDA 510(k)
FDA Class 1
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517070791·Sterilization Tray CR-L Narrow
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446638·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446652·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446669·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012023·PedFuse Respond, SLD, 7.0mm x 60mm
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446614·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446621·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446645·
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
FDA 510(k)
FDA Class 1
·General Hospital
MODEL 6900GE-64: C-SPINE ARRAY
FDA 510(k)
FDA Class 2
·Radiology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·March 1, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·March 10, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 12, 2008
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 29, 2021
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
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025