17 results · 21ms · Sources: EU EUDAMED, 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