15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Da Vinci SP Surgical System (SP1098)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mediflex 3.5mm Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102100406·Metz Scissors, Curve w/ Flush Port & non-Lockin...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020096·INTRG WHISP-Z ROTH BIC-7T 0A 018 UP
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L23003301K0·Conical Abutment
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L23003302K0·Conical Abutment
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L23003303K0·Conical Abutment
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
FDA 510(k)
FDA Class 2
·Orthopedic
VERIGENE BC-GP UTILITY REAGENT KIT
FDA Adverse Event
Malfunction
·LUMINEX CORPORATION·Product code PAM·October 16, 2023
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code NIM·November 12, 2008
CONSULTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·August 31, 2011
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 16, 2013
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025