17 results · 30ms · Sources: EU EUDAMED, US FDA

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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