16 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Joule System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
FDA 510(k)
FDA Class 2
·Cardiovascular
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 14, 2002
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·September 13, 2016
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code LGW·June 14, 2013
LIVEWIRE STEERABLE DUO-DECA
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DRF·July 5, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 2, 2016
SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code NEW·October 24, 2024
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
Allura CV20, system code 722031
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026