21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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