19 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.

reVive Light Therapy® Wrinkle and Acne LED Device

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

MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·January 19, 2024

REFLOW ASPIRATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500

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

MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2022

M.U.S.T. PEDICLE SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025

PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·November 8, 2023

M.U.S.T. PEDICLE SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·July 16, 2025

MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·February 16, 2022

MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN

FDA Adverse Event
Death ·MEDACTA INTERNATIONAL SA·Product code NKB·March 29, 2023

ENTITY DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008

SERVO-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 8, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 12, 2013

MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·July 7, 2021

MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·November 3, 2021

MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·June 25, 2024

Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds.

FDA Enforcement
Class II ·Terminated·ASO, LLC·August 14, 2013

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026