15 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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SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
FDA 510(k)
FDA Class 2
·Radiology
JOBST Men's Dress
FDA UDI
BSN MEDICAL, INC.·00035664107987·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE LAR...
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231107980·BONN Tissue Forceps Very Delicate 1x2 Teeth, .1...
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
FDA 510(k)
FDA Class 2
·General Hospital
RUSCH CANTOR TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·September 23, 2014
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2021
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025