20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Varian Head Frame
FDA 510(k)
FDA Class 2
·Radiology
VascuTrak®
FDA UDI
Bard Peripheral Vascular, Inc.·00801741061219·VascuTrak® PTA Dilatation Catheter 2.5 mm x 60 ...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776393267·Deschamps Ligature Carrier, 8". blunt right
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916134556·ZEUS®-L, Lateral Lumber Interbody Fusion Device...
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141608·ZEUS® LLIF 14mm x 25mm x 60mm x 21° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141530·ZEUS® LLIF 14mm x 25mm x 60mm x 07° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120498·ZEUS®-L, Lateral Lumber Interbody Fusion Device...
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141578·ZEUS® LLIF 14mm x 25mm x 60mm x 14° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120481·ZEUS®-L Hyper, 14 x 25 x 60mm, 14 Degree
REPROCESSED PULSE OXIMETER SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
STELLAR 404 MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 14, 2024
VECTRA-T-PL 4/4.5 2 SEGMENTS L55 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KWQ·June 3, 2013
JUVEDERM VOLUMA XC 27G X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·September 30, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·June 20, 2011
COMPREHENSIVE REVERSE ARCOM XL 44-36 STD HUMERAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 31, 2018
CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
FDA Adverse Event
Malfunction
·UMKIRCH·Product code LXH·March 11, 2016
COMPREHENSIVE REVERSE ARCOM XL 44-36 STD HUMERAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 31, 2018
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018
PKG, 3MM X 20CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282104 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