18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RG 3ml Medication Cartridge
FDA 510(k)
FDA Class 2
·General Hospital
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023301·400 Micron SU Thulio Performance 4.5m Fiber
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512688·"An absorbent paper points is an endodontic pap...
NA
FDA UDI
aap Implantate AG·04042409065743·Mini L-Plate 2.0, oblique L, 4 holes
NA
FDA UDI
aap Implantate AG·04042409065750·Mini L-Plate 2.0, oblique L, 4 holes
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
FDA 510(k)
FDA Class 1
·Anesthesiology
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 27, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·July 2, 2013
SPIDER FX
FDA Adverse Event
Injury
·COVIDIEN·Product code NTE·October 20, 2016
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 5, 2018
UNK - CONSTRUCTS: PHILOS PLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·April 16, 2026
IMPLANTABLE INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·February 1, 2016
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
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