28 results · 22ms · Sources: EU EUDAMED, US FDA

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EPIEN Dental Cleanser

FDA 510(k)
FDA Unclassified ·Unknown

HHM

FDA UDI
Oticon A/S·05707131355171·G300 SC, MINIRITE 312 2.4G C094 HHM

7450 RV2 MASK

FDA UDI
HANS RUDOLPH, INC.·00817136024929·7450 XS FACE MASK-HDGR 22mmOD

Disposable Blade

FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50

Stratum™ Reduced Size Foot Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

SURGISIS PERIPHERAL VASCULAR PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

2520274-2013-06518

FDA Adverse Event
Injury ·SYNTHES, USA·Product code HWC·September 25, 2013

2520274-2013-06522

FDA Adverse Event
Injury ·SYNTHES, USA·Product code HRS·September 25, 2013

2530088-2013-01203

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code MJO·September 30, 2013

2520274-2013-06607

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·September 30, 2013

QUARTET LEAD DOUBLE BEND, 86 CM

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code OJX·September 15, 2023

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code MEA·July 20, 2023

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·December 21, 2021

GE OEC 9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008

ACTIVA PC

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 5, 2011

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 2, 2013

POUNCE VENOUS THROMBECTOMY SYSTEM

FDA Adverse Event
Injury ·SURMODICS INC·Product code QEW·May 16, 2024

SYNERGY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·March 18, 2022

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code MIH·October 13, 2017