30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Restoris Multi-Compartmental Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Ormco
FDA UDI
ORMCO CORPORATION·00889989031294·SPRING COIL CLOSE WOUND PKG 009 X 030
priti®multidisc ZrO2
FDA UDI
Pritidenta GmbH·04251366905096·
Tizian Blank 5.0
FDA UDI
Pritidenta GmbH·04251366906130·
V2 TRIVERSE LOCKING BAR PI
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125417·
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
QT SCANNER 2000 MODEL A
FDA Adverse Event
Injury
·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025
NEUTRAL LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·June 27, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·September 12, 2018
LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022