17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RABEA SPINAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Bard® Dimension® Stone Basket
FDA UDI
C. R. Bard, Inc.·00801741066856·Bard® Dimension® Stone Basket
GALEMED CORP.
FDA registration
GALEMED CORP.·33 products·🇹🇼 Taiwan
OTI CERAMIC FEMORAL HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SICKLE-CHEX
FDA 510(k)
FDA Class 2
·Hematology
8043316-2019-00001
FDA Adverse Event
Malfunction
·May 31, 2019
EPD 60000 RPM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 9, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·February 25, 2011
VITALITY AVT
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 15, 2019
DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZI·September 3, 2013
CABLE 3M TO CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
1077 MADSEN ACCUSCREEN, ABR/TE INCLUDING STANDARD ACCESSORIES INCL. PROBE
FDA Adverse Event
Malfunction
·NATUS MEDICAL DENMARK·Product code EWO·February 11, 2021
ICS CHARTR 200
FDA Adverse Event
Malfunction
·NATUS MEDICAL DENMARK (GN OTOMETRICS)·Product code GWN·September 5, 2019
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024