14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EARP Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
URO PRO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Quickie, Zippie
FDA 510(k)
FDA Class 2
·Physical Medicine
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
CURRENT RF VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·September 20, 2018
PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014