20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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