28 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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DERMABOND PRINEO Skin Closure System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020282·FPS 3.5mm x 12mm Standard Screw
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154131822·DRILL F. 12MM SCREWS, DENTAL SHAFT
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981038205·35x27mm Trial 12mm 12 deg. The Vu a-POD interve...
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OsteoMed
FDA UDI
OSTEOMED LLC·00845694074285·FPS 3.5 x 12mm Screw Sterile Qty 2
InFill V2 Lateral PE
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729020818·
STERILE TRAC SYSTEM 12 PACK
FDA UDI
BIOMET MICROFIXATION, INC·00841036199005·
InFill V2 Lateral PE
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729020856·
InFill V2 Lateral PE
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729020887·
InFill V2 Lateral PE
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729020771·
STERILE TRAC SYSTEM 12 PACK
FDA UDI
BIOMET MICROFIXATION, INC·00888233020992·
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
ENDO STITCH POLYSORB 0 48 U/D DLU SU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code MFJ·October 27, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026