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

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UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD

FDA 510(k)
FDA Class 2 ·Orthopedic

Trilogy 100

FDA UDI
Respironics, Inc.·00606959048324·Detachable Battery Pack, USA / International

TI-DBLE LEAD CORT SCR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018

OSSEOTITE DENTAL IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755

FDA 510(k)
FDA Class 2 ·Cardiovascular

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·April 9, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·March 28, 2011

VENTAK PRIZM 2 DR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

BALANCE PRIMARY HIP 9 X150 RT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 14, 2020

M2A MODULAR HEAD COMPONENT STANDARD NECK

FDA Adverse Event
Injury ·.·Product code KWA·May 21, 2019

UNKNOWN HIP FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021

TRI-LOCK BPS SZ 4 HI OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015

TRI-LOCK BPS SZ 7 STD OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 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