12 results
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28ms
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Sources: EU EUDAMED, US FDA
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS
FDA 510(k)
FDA Class 1
·Dental
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031469·Rhoton® Hook, Nerve, 90° Angle, Semi-Sharp Tip,...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209133215·
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776355036·R-Type Hook,
ACUMED
FDA UDI
Acumed LLC·10806378051050·Half-Size Compression Device Caddy Tray
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·April 25, 2014
MESH COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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