15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ICS MEDICAL CHARTR OAE WITH TYMP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 19, 2024
BD DURASAFE¿ COMBINED ANESTHESIA KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code CAZ·October 10, 2017
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 26, 2013
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code IZL·April 21, 2011
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·July 23, 2008
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
BD DURASAFE¿ COMBINED ANESTHESIA KIT
FDA Adverse Event
Injury
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code CAZ·August 18, 2017
LEGION HK HINGE KNEE SYSTEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012