20 results · 24ms · Sources: EU EUDAMED, US FDA

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MS-39

FDA 510(k)
FDA Class 2 ·Ophthalmic

BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™

FDA UDI
BECTON, DICKINSON AND COMPANY·10382902216015·BD BBL™ Columbia CNA Agar with 5% Sheep Blood a...

Teleflex Medical LLC

FDA registration
Teleflex Medical LLC·15 products·🇺🇸 United States

Portex

FDA UDI
ICU MEDICAL, INC.·15019517085822·

UNKNOWN ¿ IMPLANT

FDA Adverse Event
Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·April 23, 2024

SEPRAMESH IP

FDA Adverse Event
Injury ·GENZYME BIOSURGERY·Product code MCN·June 24, 2005

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

DENALI MI Spinal System

FDA UDI
VB Spine LLC·10888857185425·MI Rod Reducer

SEPRAMESH IP

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 10, 2008

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 3, 2014

COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETE

FDA Adverse Event
Injury ·COOK, INC.·Product code FOZ·August 19, 2011

THERMOPHORE AUTOMATIC MOIST HEAT PACK

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·July 1, 2013

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 12, 2016

THE SCOPE PROBE¿

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·September 26, 2024

BD BBL¿ COLUMBIA CNA AGAR W/5% SB// MACCONKEY II AGAR

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSJ·July 25, 2024

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

FDA Recall
Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021