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