28 results · 22ms · Sources: EU EUDAMED, 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