20 results · 31ms · Sources: EU EUDAMED, 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