19 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Ponto
FDA UDI
Oticon Medical AB·05712149026500·PONTO 5 SUPERPOWER, CBE
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113967·HYDRO-DISSECT CANNULA 25GA ANGLED 7MM
TriVerse Asymmetric Patella Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097608·
U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
FDA 510(k)
FDA Class 2
·General Hospital
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CERTAIN® GOLD-TITE® HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·March 17, 2022
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 8, 2025
ADVANIX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 4, 2014
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 16, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 12, 2013
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025
CR TIBIAL INSERT SZ3, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 14, 2023
ADVANIX BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 4, 2025
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018