15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450384794·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450390351·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0193000·Caliper, Rod Measurement, MIS
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702357011·E2/AD/CT-E/GRE
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
FDA 510(k)
FDA Class 2
·General Hospital
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCLAIM ENCORE
FDA Adverse Event
Other
·ABBOTT LABORATORIES·Product code FRN·September 17, 1999
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 27, 2025
PASSPORT V AND TRIO MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 20, 2011
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 13, 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