18 results · 29ms · Sources: EU EUDAMED, 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