13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
FDA 510(k)
FDA Unclassified
·Unknown
ArgenZ HT+ 95x30 A3.5
FDA UDI
ARGEN CORPORATION, THE·D818122812·Dental porcelain/ceramic restoration kit
LEFORTE NEURO SYSTEM BONE PLATE
FDA 510(k)
FDA Class 2
·Neurology
GAMMA-BSM; BETA-BSM; EQUIVABONE
FDA 510(k)
FDA Class 2
·Dental
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 21, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011
VISTASEAL DUAL APPLICATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code MZM·July 20, 2023
VISTASEAL DUAL APPLICATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code MZM·July 14, 2023
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023