13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO RENEW LEAD EXTENSION
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032751·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm B...
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALOS BONE GRAFT MATERIAL
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER® ONE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 28, 2023
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 28, 2022
31" (79 CM) APPX 3.3 ML, EXT SET W/CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·May 31, 2023
HUDSON AQUATHERM III ELECTRONIC HEATER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZE·March 29, 2013
POLY-L-LACTIC ACID
FDA Adverse Event
SANOFIAVENTIS U.S. LLC·Product code LMH·March 24, 2011
CAPTURE-R READY SCREEN TEST WELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 24, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018