27 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KARL STORZ 3D VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092122730·Straumann® TL WN-compatible Ti Base x 6mm
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001362·artVeneer life lower anteriors, UIS, C2
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143621·
NIH™
FDA UDI
MEDTRONIC, INC.·00613994964489·WVN CATHETER 001362 10PK 8F 100CM NIH
AirLife™
FDA UDI
AIRLIFE·10889483570135·AirLife™ Adult Oxygen Mask Vinyl, Under-the-Chi...
NIH™
FDA UDI
MEDTRONIC, INC.·00763000199302·WVN CATHETER 001362 10PK 8F 100CM NIH
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752116276·AirLife™ Adult Oxygen Mask Vinyl, Under-the-Chi...
Elite Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001362·CEI 595 Shaver, 8mm
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
GOLDFINGER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
TUFF UNICON IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·December 29, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
TUFF UNICON IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 12, 2025
AIRLIFE ADULT OXYGEN MASK VINYL
FDA Adverse Event
Injury
·VYAIRE MEDICAL INC.·Product code CAT·August 4, 2021
2520274-2013-01422
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 13, 2013
CAPSURE SP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 25, 2011
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MLD·February 20, 2008
TUBE CEV6795B DIA 5MM 350MM
FDA Adverse Event
Injury
·INTEGRA MICROFRANCE S.A.S.·Product code GEI·November 12, 2019