19 results
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35ms
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Sources: EU EUDAMED, US FDA
TURBOTRON 20/20
FDA 510(k)
FDA Class 2
·Ophthalmic
Offset Regulation Module
FDA UDI
ADLER ORTHO SPA·08052693623785·OFFSET REGULATION MODULE TIBIA PHANTOM PANTHEON 2
HARPOON
FDA UDI
Biomet Sports Medicine, LLC·00880304001145·
OSS POLY TIBIAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
OSS CEMENTED IM STEM 9MMX90MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227972·Royce Ear Knife, 7mm, cutting bld
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490499842·INNER TRAY 902-920 ANTERIOR 20MM INST
OSS REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
OSS RS 12MM LS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
OSS RS AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
OSS RS 3 CM RESURF FMRL-LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
OSS RS POLY FEM BUSHINGS SET/2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·March 20, 2019
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
FDA 510(k)
FDA Class 2
·Ophthalmic
ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2019
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 26, 2007
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·November 29, 2012
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