18 results · 23ms · 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.

Nihon Kohden SVM-7200 Series Vital Signs Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Oticon A/S·05707131339195·SIYA 2, MRITE 312 2.4G NFM PB C092

HAMILTON-C2

FDA 510(k)
FDA Class 2 ·Anesthesiology

ZEISS INFRARED 800 WITH FLOW 800 OPTION

FDA 510(k)
FDA Class 2 ·Radiology

UNIVERSAL BLOCK TRAY

FDA Adverse Event
Malfunction ·INTEGRA PAIN MANAGEMENT·Product code FMF·June 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 16, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

BD PHOENIX PMIC110

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021

BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

BD PHOENIX PANEL PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025

BD PHOENIX PANEL PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023

bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024