12 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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FUJIFILM SonoSite X-Porte Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036054793·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197496018·RZ Rainer Curette
backwa...
PINN DELTA CER INSRT 58ODX36ID
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code MRA·January 3, 2012
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
FDA 510(k)
FDA Class 2
·Cardiovascular
ENCODE PATIENT SPECIFIC ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
STARDRIVE SCREWDRIVER SHAFT T8 105MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code KWQ·September 27, 2016
AMISTEM H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2026
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·July 7, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
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