21 results · 22ms · Sources: EU EUDAMED, US FDA

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CERASORB ORTHO

FDA 510(k)
FDA Class 2 ·Orthopedic

INSET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 12, 2026

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033567449·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033567401·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033567456·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033567432·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033567425·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033567418·

Bathtub

FDA UDI
Ropox A/S·05707581000379·

Bathtub

FDA UDI
Ropox A/S·05707581004124·

NA

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 7, 2012

SLEEP PAT 200 DEVICE

FDA 510(k)
FDA Class 2 ·Anesthesiology

BCI 3403 SLEEP SCREENING PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ONYX

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code MFE·February 16, 2015

DIAGNOSTIC CARDIOLOGY CATHETER- 6F

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code DQO·March 19, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

ISOFLEX S

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

ICY HOT HEAT THERAPY PATCH

FDA Adverse Event
Other ·CHATTEM, INC.·Product code IMD·March 13, 2008

MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAN·August 12, 2021

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