30 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWERPICC SV CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·November 20, 2024
GUS
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436113083·G14TC-3-EU
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973271·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971178·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970010·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970027·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172972991·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974018·UniTip High Resolution Catheter 10F
RAPID DRUG SCREEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SNORE SAT RECORDER, MODEL SS41
FDA 510(k)
FDA Class 2
·Anesthesiology
VERSAFITCUP HIGHCROSS LINER
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code MEH·January 14, 2011
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·November 9, 2016
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013
OPHTHALAS 532 EYELITE LASER SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code GEX·September 17, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
1.7MM COCR CABLE WITH TI CRIMP 750MM-STERILE
FDA Adverse Event
Injury
·RTI SURGICAL·Product code JDQ·May 1, 2019
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025