51 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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3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595538·TRIAL 2191355 O25 IB 27MM 6 DEG 12X55
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032207·ET20 MNR, 2.4G NFM PB BR ENCHANT 20
Sklar®
FDA UDI
SKLAR CORPORATION·10649111386497·TISSUE FCP FLUTED HDL 1X2 7IN
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105514R1·IN-OVATION® mini Rhodium Base Rx 018 UL/5-5 CS ...
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055241·IN-OVATION® mini Base Rx 022 UL/5-5 CS BC HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523P1·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK PSV
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055131·IN-OVATION® mini Base Rx 018 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055231·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105524R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS B...
AUGEASE VASCULAR AUGMENTATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 21, 2014
PLEXUR M
FDA Adverse Event
Injury
·OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)·Product code MQV·June 26, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 28, 2011
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·November 19, 2018
BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·November 30, 2018