18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE VITRECTOMY LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810120961·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040099933·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040140830·Maxima Gutta Percha CC 20/Vl
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040008829·Zirlux 16+ B4 89x17x20
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01209N0·Cervical Trial, 15 x 12, 9mm, 0 Degree, No Taper
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521012096D0·12 x 95 mm SI Implant with HA Coating
CONTACT DETACH
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 23, 2025
MULTI CARE THERAPEUTIC VIBRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 14, 2007
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024