16 results · 27ms · Sources: EU EUDAMED, US FDA

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CAIMAN SEAL AND CUT TECHNOLOGY

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

COMPLETE BLINK-N-CLEAN LENS DROPS

FDA 510(k)
FDA Class 2 ·Ophthalmic

BARIREP

FDA 510(k)
FDA Unclassified ·Unknown

COMPLETE

FDA Adverse Event
Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020

MAXZERO

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 31, 2013

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·May 31, 2011

XMAX MOTOR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 3, 2014

BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

BD MAXZERO¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

MAXZERO NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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

C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013