42 results · 25ms · Sources: EU EUDAMED, US FDA

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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