17 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776176341·Volkman Curette , double ended, roundoval
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772826346·LUMBAMED SACRO, GREY, III
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184058·Integra® Jarit® Volkman Bone Curette, 6-1/2", D...
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021053·FM3 - Embla
Sapphire II Pro
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942457·Balloon Dilatation Catheter
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Infrascanner
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 15, 2024
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2013
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·November 6, 2024
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·May 13, 2020
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·August 28, 2019
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020