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