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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MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694612·Digital Analog for Lab, WP, inc. Screw
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802232·Jones Clip Towel Forceps, 9cm
HARDYDISK, CEFOTAXIME 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
PATIENTNET MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 28, 2025
WALKMED® 150 ML RESERVOIR BAG
FDA Adverse Event
Malfunction
·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 17, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 29, 2011
FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code GAS·July 1, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 18, 2024