30 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Neo-Tee T-Piece Resuscitator
FDA UDI
MERCURY ENTERPRISES, INC.·10641043508046·
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113888·LOCATOR R-Tx Abutment for Wide Platform (WP) In...
LEONE SPA
FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121074·LOCATOR F-Tx Abutment For Wide Platform (WP) In...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128998·LOCATOR R-Tx Abutment, WP Conical Connection, 4...
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9611993-2025-050804
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·February 25, 2025
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·April 10, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·March 15, 2011
SYNCHRONY II
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012