21 results · 32ms · Sources: EU EUDAMED, US FDA

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CLAVE STOPCOCK

FDA 510(k)
FDA Class 2 ·General Hospital

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014604336·AMSCO 1080/2080 2.25"SOFTCARE PLUS FOAM W/ SOFT...

Disposable Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935102366·

HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

STERIS AMSCO MILLENNIUM STEAM STERILIZER

FDA 510(k)
FDA Class 2 ·General Hospital

CELOX GAUZE

FDA Adverse Event
Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

CELOX GAUZE

FDA Adverse Event
Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 26, 2013

MINICAP TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 6, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 16, 2008

ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·February 24, 2017

ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK INC·Product code NIO·July 25, 2017

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·September 11, 2023

CELOX GAUZE

FDA Adverse Event
Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Injury ·BD (SUZHOU)·Product code FOZ·August 18, 2023

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Injury ·BD (SUZHOU)·Product code FOZ·September 19, 2023

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·August 16, 2023

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 23, 2024

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026