19 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DR. HAYS BITE GUARD
FDA 510(k)
FDA Unclassified
·Unknown
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563144·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01407N0·Cervical Rasp, 15 x 12, 7mm, 0 Degree, No Taper
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563137·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563106·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563090·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01407T0·Cervical Rasp, 15 x 12, 7mm, 7 Degree, Tapered
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563113·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563083·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033563120·
INSET 30
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·November 20, 2025
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
IDENTITY ADX XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
BIORAPTOR 2.9 W/ ULTRABRAID
FDA Adverse Event
Malfunction
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code MBI·March 14, 2008
BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 21, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022