18 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BUSSE PLASTIC LOR SYRINGE
FDA 510(k)
FDA Class 2
·Anesthesiology
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113628·LOCATOR R-Tx Abutment for 5.0mm Conelog Connect...
LEONE SPA
FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red
Arthrex®
FDA UDI
ARTHREX, INC.·00888867186538·JumpStart, 8" X 8", Single Layer
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182840·
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
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2019
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 16, 2025
EMAX2PLUS
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 6, 2011
4.5MM CORTEX SCREWS
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·July 17, 2008
SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017
1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
FDA Recall
Terminated
·Spinal Concepts, Inc·Product code KWQ·March 1, 2004
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018