20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALCULASE II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925017429·GOLDENBERG MALLEABLE PORP PROSTHESIS PARTIALLY ...
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 21, 2011
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD. UK·Product code KWY·August 28, 2008
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 28, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2018
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 23, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·June 14, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 26, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·June 13, 2019
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·September 12, 2018
TFNA FEM NAIL Ø11 R 125° L360 TIMO15
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·January 8, 2020
FLIPPER MREYE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2019
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·October 11, 2022
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013