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

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E-Z Chek Chlorine Residual Test Strips (K100-0101B)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SCANLAN® Dr. Moline Clip

FDA UDI
SCANLAN INTERNATIONAL INC·00846159026351·Dr. Moline Clip

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00842180148130·SURGEONS STOOL, WITH BACKREST, HEIGHT ADJUSTMEN...

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506089459·KNOB FOR BACKREST ADJUSTMENT ON SURGEONS STOOL ...

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

NEXXIS OR

FDA 510(k)
FDA Class 2 ·Cardiovascular

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·March 31, 2010

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·March 5, 2010

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·December 30, 2002

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 10, 2010

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·February 12, 2010

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·February 12, 2010

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·February 12, 2010

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

4000CMS

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 2, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·November 13, 2015

INRATIO2

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·March 16, 2010

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025