18 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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V-ONESTEP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517639493·CoRoent Ant TLIF PEEK, 9x13x28mm 15°
Edge™ Diamond TS012-8SC Tapered Shoulder
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003544·Diamond dental bur, reusable
HHM
FDA UDI
Oticon A/S·05707131341006·G200, BTE 13 2.4G 85 C092 HHM
CHIMAERA Hip Fracture System
FDA UDI
ORTHOFIX SRL·18056099649230·4.2MM DISTAL DRILL BIT - SHORT
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 6, 2002
MODIFICATION TO LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIXTAL DZ-4100 SERIES PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2024
BOJRAB ALTO TOTAL OR PARTIAL PROSTHESES
FDA Adverse Event
Injury
·GRACE MEDICAL, INC.·Product code ETA·October 7, 2008
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·June 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026