18 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2
FDA 510(k)
FDA Class 2
·Cardiovascular
Amara View
FDA UDI
Respironics, Inc.·00606959009172·Amara View Mask without Headgear, Medium
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477641·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106130·Trial, 26 x 13mm, 8 Degree, Tapered, Straight
Phonak
FDA UDI
Phonak AG·07612847818477·Phonak Ambra microP (pure transparent)
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962108765·PROBE, 5", DOUBLE ENDED, SLIVER
MAGELLAN-2200, MODEL 1
FDA 510(k)
FDA Class 2
·Anesthesiology
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
FDA 510(k)
FDA Class 2
·Cardiovascular
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 2, 2013
5MM PEEK MULTIFUNCTION HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·September 15, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
NAVARRE UNIVERSAL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD) -3006260740·Product code GBX·December 18, 2023
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018