30 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780413806·Integra® Jarit® Sistrunk Scissors, 5-1/4", Slig...
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479194731·TAPE, PAPER PREM 3"X10YDS
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958000065·10 Units of 600 Micron Disposable ND YAG Laser...
COOLEY PATENT DUCTUS CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002043·COOLEY PATENT DUCTUS CLAMP STRAIGHT JAW ANGLED ...
COOLEY PATENT DUCTUS CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921001950·COOLEY PATENT DUCTUS CLAMP STRAIGHT JAW ANGLED ...
Mariner MIS
FDA UDI
Seaspine Orthopedics Corporation·10889981297961·MIS Locking Navigation Driver
Scanlan® SURG-I-BAND® color coding
FDA UDI
SCANLAN INTERNATIONAL INC·00846159001501·Scanlan® SURG-I-BAND® color coding - Original, ...
Immunalysis
FDA UDI
IMMUNALYSIS CORP·00840937108710·Fentanyl Urine Calibrator 1
Accuryn Monitor Floor Stand
FDA UDI
POTRERO MEDICAL, INC.·00850019755220·The Accuryn Monitor Floor Stand is used to hold...
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
PREMIER ULTRASONIC SCALER AND INSERTS
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 6, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 20, 2021
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·May 22, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 17, 2021
BINAXNOW COVID-19 AG CARD HOME TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 17, 2022
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 8, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·September 18, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 16, 2011