27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
FDA 510(k)
FDA Class 2
·Orthopedic
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741105180·Catheter Placement Kit
Bard® Adapter and Tubing
FDA UDI
C. R. Bard, Inc.·00801741045745·Bard® Adapter and Tubing for Leg Bags to Male E...
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0005381·CC/ Dentine D-B3
OCCUPAK CAT.#200-0538
FDA 510(k)GeneXpert Infinity-48s System
FDA UDI
CEPHEID·07332940004330·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450148075·
Non-Telescopic PenEvac
FDA UDI
I.C. MEDICAL, INC.·00817688020776·
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
FDA 510(k)
FDA Class 1
·General Hospital
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 9, 2026
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·June 19, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 24, 2011
LECTROVAC II 6-INCH
FDA Adverse Event
Malfunction
·COVIDIEN LP (BOULDER)·Product code GEI·February 11, 2008
TI CERVICAL SPINE LOCKING PLATE 45MM (37MM)
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·September 9, 2015
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024