20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040010693·Zirlux 16+ C3 100X20
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422861·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422878·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422946·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422816·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422854·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422915·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033422885·
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·September 26, 2017
RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON ?11X34
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·December 19, 2012
5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·September 26, 2017
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 22, 2025
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·March 19, 2013
54CM BIPOLAR LEAD
FDA Adverse Event
Injury
·GREATBATCH MEDICAL·Product code DTB·March 7, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024