21 results · 23ms · Sources: EU EUDAMED, US FDA

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IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)

FDA 510(k)
FDA Class 2 ·Dental

Zethon

FDA UDI
ZETHON LIMITED·05060528013550·MFP-120 - MULTIFUNCTION FOOT PEDAL - WIRED

Neodent

FDA UDI
JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047261·NGS NARROW TAPERED DRILL

RINGLOC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304229655·

RINGLOC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304001497·

MEDIUM 199, 10X CATALOG NO. 210-3556

FDA 510(k)
FDA Class 1 ·Hematology

SELF CENTERING

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295003465·SELF CENTERING BI-POLAR HEAD 28mm ID 56mm OD

HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG

FDA 510(k)
FDA Class 2 ·Microbiology

MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·July 30, 2021

MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·May 8, 2023

MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·May 12, 2023

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 9, 2013

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL COMPANY·Product code MTA·September 19, 2014

ELEVATE

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·May 23, 2011

VCARE 200A - MEDIUM

FDA Adverse Event
Malfunction ·CONMED UTICA·Product code LKF·September 22, 2021

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

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021