34 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
FDA 510(k)
FDA Class 2
·General Hospital
SUPERCUT METZENBAUM SCS 7 CVD
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES MANSFIELD·Product code DWS·February 9, 2022
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300508·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780375173·Integra® Jarit® Metzenbaum Scissors, 7", Superc...
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331153471·probe w/ eye, stainless steel, 4 1/2" (11.4 cm)
Drive
FDA UDI
Drive Devilbiss Healthcare·50822383100604·Walkr,Adlt,1-Btn,w/5""whls,2/cs
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021220·SPIRA®-A Integrated,Trial, 30x34mm, 8° Lordotic...
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857520134·Straight Blade, Size 30x150 mm
MI (Mini Incision) Driver - Green
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215164768·
VECTOR
FDA 510(k)
FDA Class 2
·Dental
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
FDA 510(k)
FDA Class 1
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 28, 2022
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·June 11, 2020
PLUM 360 DRIVER NEW
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FRN·January 2, 2020
PLUM 360 DRIVER NEW
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FRN·December 30, 2019
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 27, 2023
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·April 26, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 19, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011
PSS UNKNOWN
FDA Adverse Event
Injury
·MDT POWERED SURGICAL SOLUTIONS·Product code HBE·November 7, 2025