28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NYDIAG 200
FDA 510(k)
FDA Unclassified
·Unknown
CoRoent
FDA UDI
Nuvasive, Inc.·00887517573759·CoRoent Ant TLIF Ti, 10x12x36mm 4°
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664010089·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...
CIV-Clear™ Transducer Cover
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436120293·Sterile (8.9x91.5cm) telescopically-folded cover
Portex
FDA UDI
ICU MEDICAL, INC.·15019517071382·
K012364
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015
AML HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PROTEMP H
FDA 510(k)
FDA Class 2
·Dental
VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015
QUADROX-I NEO. MIT RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
OXYGENRATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015
ACRYSOF RESTOR
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 30, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·September 19, 2014
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 20, 2011
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 5, 2026
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 15, 2021
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·July 31, 2024
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013