42 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PDT DOSECALCULATOR, MODEL 80000
FDA 510(k)
FDA Class 2
·Anesthesiology
Dissector
FDA UDI
ATRICURE, INC.·10840143902130·Articulating Dissection Instrument, 18 cm shaft
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501785·TeWa CB-Type 2015 (s): uncoated acupuncture ne...
TEWA
FDA UDI
asia-med GmbH·04251282509101·TeWa CB-Type 2015 (s): uncoated acupuncture ne...
Dissector
FDA UDI
ATRICURE, INC.·00818354010541·Articulating Dissection Instrument, 18 cm shaft
Augurex
FDA UDI
Augurex Life Sciences Corp·00628425360006·14-3-3eta SRM NEG, 10-pack, ASR
ONESTEP
FDA UDI
Zoll Medical Corporation·00847946021238·ONESTEP PACING ELECTRODE, FC, SINGLE
N/A
FDA UDI
PENTAX OF AMERICA, INC.·04961333244300·HANDLE FOR 2"/5 CM POST
Speculum Tubing
FDA UDI
I.C. MEDICAL, INC.·00817688021414·
RGP MULTI-PURPOSE SOLUTION ID 100136
FDA 510(k)
FDA Class 2
·Ophthalmic
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
DIMENSION RXL MAX WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·March 12, 2013
TDXFLX SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJQ·February 24, 2011
GAMBRO CARTRIDGE BLOOD SET
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·February 20, 2008
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·October 1, 2024
INSORB 30 STAPLER
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code GDW·November 1, 2023
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
INFUSE BONE GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·February 27, 2024
CMD 20-1413 GLENOID IMPLANT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·March 11, 2022
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 9, 2014