18 results · 24ms · 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.

TXCELL SCANNING LASER DELIVERY SYSTEM

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

JOBST UltraSheer

FDA UDI
BSN MEDICAL, INC.·00035664214753·ULTRA SHEER 30-40 MM HG KNEE HIGH CLOSED TOE LA...

TRIDENT SPLITTER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896072596·TRIDENT SPLITTER STRAIGHT TIP TITANIUM

VuMesh™

FDA UDI
Seaspine Orthopedics Corporation·10889981036621·14mm Sq 7.5 Deg End Cap

COMPRESS ANTI-ROTATION SPINDLES

FDA 510(k)
FDA Class 3 ·Orthopedic

BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET

FDA 510(k)
FDA Class 2 ·General Hospital

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 11, 2022

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 2, 2015

BD PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 8, 2021

NEEDLE 30X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 29, 2021

BD PRECISIONGLIDE¿ NEEDLES

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 13, 2023

BD PRECISIONGLIDE¿ NEEDLES

FDA Adverse Event
Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 31, 2023

NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 18, 2019

BD PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 31, 2019

CPS TIB SPINDLE LT 12X37X42MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025