15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TruDi Curette
FDA 510(k)
FDA Class 2
·Neurology
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958003967·600 Micron ND Laser Calibration Lightguide, Lue...
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958001307·Medilas D FlexiPulse Diode Laser, D-Plug
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114049·J-SHAPED CANNULA 25GA STRAIGHT (PK/10)
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011740·LIPOSUCTION CANNULA COBRA
COSMED QUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
BD PLASTIPAK¿ SYRINGES
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·August 10, 2022
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
TERUMO ADVANCED PERFUSION SYSTEM I
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 29, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 27, 2014
TRIMA ACCEL
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·July 2, 2013
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020