20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OVOMotion Reverse Shoulder Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Esprit™
FDA UDI
ABBOTT VASCULAR INC.·08717648357176·Esprit™ BTK Everolimus Eluting Resorbable Scaff...
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184414·Accufit Molar Bands Lower Right Second Molar 37...
Esprit™
FDA UDI
ABBOTT VASCULAR INC.·08717648357152·Esprit™ BTK Everolimus Eluting Resorbable Scaff...
Esprit™
FDA UDI
ABBOTT VASCULAR INC.·08717648357138·Esprit™ BTK Everolimus Eluting Resorbable Scaff...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114056·J-SHAPED CANNULA 25GA ANGLED (PK/10)
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) ACCESS PORT I
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·October 14, 2008
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
ESPRIT¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code NXW·January 8, 2026
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
ESPRIT¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code NXW·January 8, 2026
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