37 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3DMax MID Anatomical Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Synthes GmbH·10886982141569·1.5MM CORTEX SCREW SELF-TAPPING 18MM
Conventional Lead Apron .5mm Small 22 X 33
FDA UDI
Flow X Ray Corporation·00843696123048·Conventional Lead Apron .5mm Small, Burgundy
GORNEY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055827·GORNEY SCISSORS CURVED DOUBLE BEVELED BLADES PO...
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
FDA 510(k)
FDA Class 1
·General Hospital
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
FDA 510(k)
FDA Class 1
·Microbiology
Widex
FDA UDI
Widex A/S·05706069735567·Widex BEYOND B-F2 (Summer gold S-220 ) Telecoil...
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·November 3, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·November 3, 2009
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 3, 2009
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 3, 2009
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 31, 2012
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·July 3, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·June 22, 2018
ENTRUST VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2012
BRAVO
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code FFT·July 14, 2008
Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 24, 2014
AVAIRA TORIC (ENFILCON A)
FDA Adverse Event
Injury
·COOPER VISION CARRIBBEAN CORP.·Product code LPL·August 8, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 2, 2013