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

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LED TURBO

FDA 510(k)
FDA Class 2 ·Dental

NA

FDA UDI
MEDTRONIC, INC.·20643169739578·ACCESS 040618 ADHESV DISK PAT LBL UPDATE

NA

FDA UDI
MEDTRONIC, INC.·20613994518853·ACCESS 040618 ANTENNA TAPE PATCH GLOBAL

N/A

FDA UDI
MEDTRONIC, INC.·20763000404264·ACCESS 040618 ADHESIVE DISC PAPER LC69

LYNX

FDA UDI
HNM TOTAL RECON LLC·00841742110646·LYNX ø3.5mm Std Cortical Screw, Full Thread, Se...

PALOMAR DERMALUX PULSED LIGHT SYSTEM

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

SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code BSP·November 21, 2019

TESS GLENOID REVERSE HEAD DIAMETER 36

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2018

STERRAD 200, SINGLE DOOR

FDA Adverse Event
Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·April 8, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 27, 2014

ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·July 5, 2023

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018