13 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Alere NT-proBNP for Alinity i Reagent Kit

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 12, 2021

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

Smith & Nephew Hip Systems

FDA 510(k)
FDA Class 2 ·Orthopedic

URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM

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

STINGRAY LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025

STINGRAY? LP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 25, 2008

CATH PKGD: WEDGE 6 FR 11 0CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC·Product code DYG·August 17, 2011

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 22, 2013

PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·October 17, 2025

PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025

PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014