18 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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da Vinci Single-Site Instrument and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K152468
FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508819·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127735·2.4 X 48mm Cannulated Headless Screw, T7
Low Profile Acetabular Reamer 48
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057510·
PULSIOFLEX
FDA 510(k)
FDA Class 2
·Cardiovascular
POCKET BREATHALYZER. CONNECTABLES
FDA 510(k)
FDA Class 1
·Clinical Toxicology
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 1, 2022
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code LWS·June 24, 2014
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LWS·June 7, 2013
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·June 22, 2011
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 31, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025