12 results · 21ms · Sources: EU EUDAMED, US FDA

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DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CENTURION SES EPIKERATOME

FDA 510(k)
FDA Class 1 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

ENDEAVOR SPRINT RX

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·May 3, 2013

NATURALYTE

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 25, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 17, 2011

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

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