15 results
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27ms
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Sources: EU EUDAMED, US FDA
ARM SLING
FDA 510(k)
FDA Class 1
·Physical Medicine
NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038015311·NUPRO® Sensodyne® Prophy Paste, Spearmint, Stai...
ACUMED
FDA UDI
Acumed LLC·10806378049569·Midshaft Forearm Hexalobe Scr Caddy Base
Symmetry Verity™
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031070·Verity Hook, Nerve, Titanium Handle, 3.0 mm Bal...
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776292348·In-Situ Bypass Hooks
MALIS
FDA Adverse Event
Malfunction
·CODMAN·Product code HAO·November 23, 2009
SYMMETRY SURGICAL
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC.·Product code GDG·July 19, 2024
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
AOC SOLUBLE IMPLANT MATERIAL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VERITY HOOK, NERVE, TITANIUM HANDLE, 3 MM BALL TIP, 7 1/4 INCH SHAFT
FDA Adverse Event
Malfunction
·SYMMETRY SURGICAL INC.·Product code GDG·October 14, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 16, 2007
ASR XL TAP SLV ADAP 12/14+5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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