18 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
1.5MM SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036073930·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321517250·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311517250·
MaxFuse,VBR, 12 (D) x 14 (W) x 18 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055998·12 (D) x 14 (W) x 18 (H)
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MOBILEDIAGNOST WDR
FDA 510(k)
FDA Class 2
·Radiology
BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code BSP·September 19, 2018
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 7, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016