229 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GKB VISION PRIVATE LIMITED
FDA registration
GKB VISION PRIVATE LIMITED·2 products·🇮🇳 India
GKB EYECARE PVT LTD
FDA registration
GKB EYECARE PVT LTD·1 product·🇮🇳 India
GKB HI-TECH MIDDLE EAST
FDA registration
GKB HI-TECH MIDDLE EAST·1 product·🇦🇪 United Arab Emirates
GKB OPHTHALMICS LIMITED - UNIT II
FDA registration
GKB OPHTHALMICS LIMITED - UNIT II·1 product·🇮🇳 India
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·June 26, 2014
BD ACCU-SED®ESR BI-LEVEL CONTROL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GKB·October 15, 2018
ELAN VESMATIC 20
FDA Adverse Event
Malfunction
·*·Product code GKB·October 2, 2001
MINIISED
FDA Adverse Event
Malfunction
·ALCOR SCIENTIFIC LLC.·Product code GKB·November 8, 2024
ACCU-SED®ESR BI-LEVEL CONTROL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GKB·July 18, 2018
VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM
FDA Adverse Event
Malfunction
·DIESSE DIAGNOSTICA SENESE SRI·Product code GKB·June 12, 2001
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002
FDA Recall
Open, Classified
·Alcor Scientific, Inc.·Product code GKB·July 20, 2022
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578
FDA Recall
Open, Classified
·Mechatronics USA·Product code GKB·April 14, 2023
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
FDA Recall
Open, Classified
·Mechatronics USA·Product code GKB·April 14, 2023
Device, Automated Sedimentation Rate
FDA classification
FDA Class 1
·Device, Automated Sedimentation Rate
Eccentric Knee Bolster
FDA UDI
Motion Concepts Inc·07540147002145·The Eccentric Knee Bolster is designed for use ...
BK-B
FDA UDI
BIOTRONIK SE & Co. KG·04035479144746·
GCB MEDICAL LLC
FDA registration
GCB MEDICAL LLC·10 products·🇺🇸 United States
GKC MANUFACTURING PTY LTD
FDA registration
GKC MANUFACTURING PTY LTD·3 products·🇦🇺 Australia
Liners
FDA UDI
SIGVARIS INC·00745129302603·A tube-like garment made of elastic material(e....
G1B PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular