17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
FDA 510(k)
FDA Class 2
·Anesthesiology
LEONE SPA
FDA UDI
LEONE SPA·08033707014096·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 29
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828186391·GEN4 INTERACTIVE
LACTOSORB® 2.0MM SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036054052·
15 MM LESIONHUNTER ROTATABLE NITINOL COLD SNARE
FDA Adverse Event
Malfunction
·MICRO-TECH (NANJING) CO., LTD.·Product code GAE·October 23, 2024
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 26, 2024
SYNGO CIRCULATION
FDA 510(k)
FDA Class 2
·Radiology
PEAK PULSAR II GENERATOR MODEL PS100-102
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PASSIVE PLUS DX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·July 7, 2011
IMP,TSV,MCOL MG,4.1MM,10M
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·January 6, 2026
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·September 3, 2014
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026