31 results · 16ms · 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.

Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA

FDA Enforcement
Class II ·Ongoing·Microcare Medical·October 2, 2024

Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; Demineralized Bone Matrix (DBM) product

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS; i) DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT; j) DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN; Demineralized Bone Matrix (DBM) product

FDA Enforcement
Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.

FDA Enforcement
Class II ·Ongoing·Edwards Lifesciences, LLC·April 6, 2022

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

FDA Enforcement
Class II ·Ongoing·Hologic, Inc·March 23, 2022

Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·March 4, 2026

medex Arterial Kit 1/EA, Product Code REF MX7827

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·October 18, 2023

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

FDA Enforcement
Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

FDA Enforcement
Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

FDA Enforcement
Class II ·Ongoing·NOA Medical Industries Inc·January 22, 2025

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

FDA Enforcement
Class II ·Ongoing·New Standard Device Inc·September 7, 2022

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

FDA Enforcement
Class II ·Ongoing·New Standard Device Inc·June 29, 2022

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

FDA Enforcement
Class II ·Ongoing·New Standard Device Inc·June 21, 2023

Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

FDA Enforcement
Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025