17 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMV Scientific Bone Screws
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131282545·H110V2, BTE 13 WL 85 TC HHM
ORTHODONTIC INSTRUMENTS
FDA UDI
Ortho Organizers, Inc.·00190707064754·DOUBLE-ENDED EXPLORER INSTRUMENT
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 30, 2017
UNITED STEM, PSA TYPE
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 6, 2013
HIP HEAD, 10/12 TAPER,28MM,+5MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 29, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 28, 2008
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
NESTER PLATINUM EMBOLIZATION MICROCOIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
MREYE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·May 11, 2018
STAINLESS STEEL EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·August 24, 2017
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015