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