18 results · 22ms · Sources: EU EUDAMED, 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