12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
FDA 510(k)
FDA Class 2
·Orthopedic
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00714171·
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 28, 2021
ULTRASOUND SCANNER, TYPE 2102
FDA 510(k)
FDA Class 2
·Radiology
ONTRAK TESTCUP 502, MODEL 3016641
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COUNTERTORQUE WRENCH FOR CSLP
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXC·April 22, 2013
S-ROM HEAD FEMORAL COCR 28+12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 13, 2011
D-TRONPLUS
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 7, 2008
ULTRASAFE X225L PNG CLEAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·August 11, 2020
STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·September 16, 2016
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 Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024