13 results · 19ms · Sources: EU EUDAMED, US FDA

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VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091033034·Baltic Denture System BDLoad Sm6 PLSEbm6DFs C4 ...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

MODIFICATION TO: THERMACOOL IIA

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

COLTENE AURA COMPOMER RESTORATIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SOLYX SIS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013

XACT CAROTID STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIM·March 29, 2011

DISP HNDSW PENCIL W/HOLSTER

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 22, 2008

EMBRYO RPLCMNT CATHETER

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.

FDA Enforcement
Class II ·Terminated·Advanced Orthogonal Equipment, Incorporated·July 31, 2013

Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use

FDA Enforcement
Class II ·Terminated·Cadence Science, Inc.·November 20, 2019

AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

FDA Enforcement
Class II ·Terminated·Primus Medical LLC·November 14, 2012

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024