13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE THERMOMETER PROBE SHEATHS
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100608·KATENA DOUBLE-X SPECULUM K-WIRE SMALL
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·May 31, 2023
APOLLO GENERATOR
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code GWG·June 11, 2015
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LWP·June 7, 2013
ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
FDA Adverse Event
Injury
·AESCULAP AG·Product code HBC·October 28, 2018
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HBC·November 5, 2018
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