10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021614·5570 QRS 3L SYRINGE
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
FDA 510(k)
FDA Class 2
·Dental
LIGAMAX 5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-BAND SYSTEM ACCESS PORT II KIT
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·May 10, 2013
BE-HQV 57104#CUSTOM PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·September 17, 2014
GENESIS PULSE GENERATOR, 8-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 2, 2011
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. 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
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021