25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
FDA 510(k)
FDA Class 2
·Orthopedic
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508598·
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·September 10, 2020
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141349·ZEUS® LLIF 14mm x 25mm x 50mm x 21° TRIAL
NA
FDA UDI
Summit Medical, Inc.·00385640002332·
Chic
FDA UDI
Gc Orthodontics America Inc.·D78814255000201·CHIC MBT 022/U5 -7T 0A 0D
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120443·ZEUS®-L Hyper, 14 x 25 x 50mm, 14 Degree
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141264·ZEUS® LLIF 14mm x 25mm x 50mm x 07° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120450·ZEUS®-L, Lateral Lumber Interbody Fusion Device...
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141318·ZEUS® LLIF 14mm x 25mm x 50mm x 14° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916134433·ZEUS®-L, Lateral Lumber Interbody Fusion Device...
Chic
FDA UDI
Gc Orthodontics America Inc.·E53514255000201·CHIC MBT 022/U5 -7T 0A 0D
MULTI-LIPID CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ELEVATE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·July 8, 2020
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·October 6, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 3, 2013
VACCESS PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·June 20, 2011
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018
PKG, COBRA FORCEPS, P/N 0250080317. 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