15 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Straumann Immediate Temporary Abutments
FDA 510(k)
FDA Class 2
·Dental
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446840954·SPECIAL, ALTIVATE REVERSE HUMERAL BROACH, 16 X ...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023189·DMTL SmartFlex 1000 High Energy Reusable (5X)
HHM
FDA UDI
Oticon A/S·05707131357212·G500 SC, MINIRITE R LI-ION 2.4G C045 HHM
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50
CODMAN
FDA UDI
Cerenovus, Inc.·10886704066774·CODMAN SLIM-LINE Aneurysm Clip Super Bayonet Bl...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383575744·Gutta Percha Points is used to root canal filin...
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MICROPAQ, MODELS 402, 404
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·October 27, 2014
ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSX·June 28, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025