19 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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PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032724·VENERE 140, SIZE ML, GLACE, GRADUATED COMPRESSI...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032724·Baltic Denture System BDLoad Mm6 PLSEbim6DFm BL...
Surgitech, Inc.
FDA registration
Surgitech, Inc.·1 product·🇺🇸 United States
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUMALINK
FDA 510(k)
FDA Class 2
·Radiology
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
FLEXI-SEAL FMS
FDA Adverse Event
Other
·CONVATEC·Product code KNT·June 7, 2006
INFINITY VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TEHCNOLOGY CTR·Product code HQC·March 29, 2013
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·March 17, 2011
PROPORT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD, INC.·Product code LJT·April 14, 2008
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 31, 2011
OT SURESTEP ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
FLEXI-SEAL FECAL MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·October 20, 2016
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 11, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 14, 2010
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024