14 results · 21ms · Sources: EU EUDAMED, US FDA

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ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

REMEL

FDA UDI
REMEL, INC.·00848838008870·Phenol Red Broth w/1% Maltose 20/PK

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496062332·RELAX UNISEX 70 OPEN TOE, SIZE S, BLU SCURO, GR...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111060465·DUAL HEAD STETH 30" BURGUNDY

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 20, 2021

JAS CARBON DIOXIDE LIQUID REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EEG SPIKE AND EVENT DETECTOR MODULE

FDA 510(k)
FDA Class 2 ·Neurology

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 16, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 12, 2011

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN-BENNETT CORP·Product code CBK·June 18, 2008

EVOLUT FX VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

ARCHITECT IPTH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code CEW·March 19, 2025

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

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