18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOCTOR SURGERY DIODE LASERS FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
tremoflo C2 Airwave Oscillometry System and Accessories
FDA UDI
Thorasys Thoracic Medical Systems Inc·07540261020360·The tremoflo C2 Airwave Oscillometry System and...
SPIRA-C
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPC1020360·Trial, 12mm x 14.5mm Lordotic 7°, 8mm
SPIRA-O
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1020360·Trial Bi-Convex 20° Lordotic, 30mm x 33mm, 19mm
SPIRA-L
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPL1020360·Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 10mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020360·SPIRA®-A Integrated,Trial, 26x34mm, 15° Lordoti...
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
FDA 510(k)
FDA Class 2
·Cardiovascular
STAIR SYSTEMS PACS & DICOM VIEWER
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 19, 2025
INFUSE BONE GRAFT 12 MG
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·May 1, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011
AUTOTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·August 7, 2008
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025