13 results · 20ms · Sources: EU EUDAMED, US FDA

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OSCAR 3

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450595121·

GYNECOLOGICAL LAPAROSCOPES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

KOWA AUTOMATED TONOMETER KT-500

FDA 510(k)
FDA Class 2 ·Ophthalmic

MEDACTA KNEE IMPLANTS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016

TRILOGY 200

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

ALLEGRETTO WAVE

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·April 30, 2013

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 16, 2014

TAXUS (R) LIBERTÉ (R)

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 18, 2011

ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·March 3, 2026

Misys Laboratory with Lab Access Results application for versions 5.3 and later.

FDA Recall
Terminated ·Misys Healthcare Systems·Product code JQP·May 13, 2005

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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