32 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Breezing Med
FDA 510(k)
FDA Class 2
·Anesthesiology
Osteotome
FDA UDI
Treace Medical Concepts, Inc.·00810111222488·Hooked Osteotome
OsteoMed
FDA UDI
OSTEOMED LLC·00845694014984·1.6mm AUTO-DRIVE Screw VISIDISK (WHITE)
KAYE FACE LIFT SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896093850·KAYE FACE LIFT SCISSORS CURVED BLADE POWER CUT ...
PATRIOT PROTRUSIO CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
CELL-CHEX
FDA 510(k)
FDA Class 2
·Hematology
Widex
FDA UDI
Widex A/S·05706069883060·WIDEX MOMENT MRB2D (Sporty red ) Telecoil, RIC ...
Widex
FDA UDI
Widex A/S·05706069689464·Widex BEYOND B-F2 (Sporty red ) Telecoil, RC co...
Widex
FDA UDI
Widex A/S·05706069744347·WIDEX EVOKE EBB3D (Sporty red ) Telecoil, RC co...
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 13, 2020
OPHTHALMIC FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021
COSMODERM 1 COLLAGEN IMPLANT (1.0ML)
FDA Adverse Event
Malfunction
·INAMED CORP. (FREMONT)·Product code LMH·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION BATTERY
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWE·July 1, 2013
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205001219·Portable Ultrasound Scanner
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
FDA Enforcement
Class II
·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021