13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114285·LACRIMAL CAN TAPPERED 19/23GA
VARIANT II TOTAL GHB
FDA 510(k)
FDA Class 2
·Hematology
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·June 29, 2022
GRAPHIC CASE FOR VEPTR II ROD INSTRUMENTS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code LXH·March 27, 2013
HGP FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·February 15, 2011
CARDIOSEAL
FDA Adverse Event
Injury
·NMT MEDICAL, INC.·Product code MLV·April 1, 2008
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012