18 results · 32ms · Sources: EU EUDAMED, US FDA

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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