18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPOCA CODR STEM AND HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0140400·Driver Shaft, T30 Final Cap Driver
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556719·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556832·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556825·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556801·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0144090·Trial, TLIF, 32L OB STR 7Deg, 9mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556818·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556795·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033556788·
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
FDA 510(k)
FDA Class 2
·Ophthalmic
PULSECO HEMODYNAMIC MONITOR CM71
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ 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
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011
ADVANCED CEMENT MIXING BOWL AN
FDA Adverse Event
Malfunction
·STRYKER PUERTO RICO·Product code JDZ·March 15, 2008
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015
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