16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACESSA GUIDANCE HANDPIECE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROFILE LITE 2
FDA UDI
Respironics, Inc.·00606959044173·Profile Lite 2 Mask with Headgear, Petite, Italy
NexxZr™ T / D-100-25-NT-OM10-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113948·
Reef TO
FDA UDI
Seaspine Orthopedics Corporation·10889981190743·Interbody, 11mm x 32mm x 18mm, 5 Deg
Reef TO
FDA UDI
Seaspine Orthopedics Corporation·10889981204891·Trial, 11mm x 32mm x 18mm, 5 Deg
CIRRUS PHOTO
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDPOR CONTAIN CAN IMPLANT
FDA 510(k)
FDA Class 2
·Dental
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 22, 2002
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 1, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 29, 2013
ZENITH FEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 14, 2011
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026