21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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