38 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)
FDA 510(k)
FDA Class 2
·Neurology
MaXcess
FDA UDI
Nuvasive, Inc.·00887517197610·MaXcess 4 Blade, 130mm Left
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864684344·Small T-Plate/Right Angled 3.5 x Head 3Holes x ...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704515237·
Pomee
FDA UDI
POMEE CORPORATION·G15772411300·Kelly forceps 5 1/2" straight
TOTAL MANDIBULAR SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036062682·
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524026030·KELLY FCP 5.5"" STR
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981030230·Screw Offset - Closed, 30mm
Sochi
FDA UDI
Altus Spine, LLC·00843210168098·Screw Offset, Closed, 30mm
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 25, 2002
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
FDA 510(k)
FDA Class 2
·Hematology
ENCOMPASS
FDA 510(k)
FDA Class 2
·Dental
AMS INFLATE/DEFLATE PUMP
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code FHW·July 26, 1994
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
FDA 510(k)
FDA Class 2
·Orthopedic
COVERED STENT
FDA Adverse Event
Injury
·Product code JCT·November 5, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 22, 2013
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023