21 results · 22ms · Sources: EU EUDAMED, US FDA

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SEFRIA PCP Oral Fluid Enzyme Immunoassay

FDA 510(k)
FDA Unclassified ·Unknown

MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN

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

NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8

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

QUICKTOX MULTIPLE DRUG DIPCARD

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

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

BD INSTRUMENT MAX CLINICAL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020

CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

FDA Adverse Event
Malfunction ·ABBOTT MFG, INC.·Product code JIX·October 17, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 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

2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HTW·August 19, 2015

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012