49 results
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27ms
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Sources: EU EUDAMED, US FDA
TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable Stainless Steel Surgical Instrument Part Number: 125382A
FDA Recall
Terminated
·Tnco, Inc.·Product code GCK·December 2, 2005
CAMBRIDGE BRAIN SCIENCES INC. (O/A CREYOS)
FDA registration
CAMBRIDGE BRAIN SCIENCES INC. (O/A CREYOS)·1 product·🇨🇦 Canada
DORO INC ( O/S DORO SAFETY & SECURITY)
FDA registration
DORO INC ( O/S DORO SAFETY & SECURITY)·1 product·🇨🇦 Canada
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 20, 2016
Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 20, 2016
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 20, 2016
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 20, 2016
Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 20, 2016
1 PROXIMATE
FDA Adverse Event
Injury
·ETHICON-ENCO-SURGERY, INC.·Product code GAG·April 6, 2001
GYC-1000
FDA Adverse Event
Malfunction
·NIDEK CO., LTD.·Product code HQF·February 4, 2016
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·November 7, 2016
SYNVISC ONE
FDA Adverse Event
Malfunction
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·January 5, 2018
KENDALL CURITY
FDA Adverse Event
Malfunction
·KENDALL CO, DIV OF TYCO INC.·Product code GES·October 24, 2002
KENDALL CURITY
FDA Adverse Event
Malfunction
·KENDALL CO, DIV OF TYCO INC.·Product code GES·October 24, 2002
CREYOS COGNITIVE ASSESSMENT PLATFORM
FDA Adverse Event
Injury
·CAMBRIDGE BRAIN SCIENCES INC. (O/A CREYOS)·Product code PTY·January 13, 2026
Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code NEP·March 8, 2016
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code NEP·March 8, 2016
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code NEP·March 8, 2016
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code NEP·March 8, 2016