20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FREND Free T4 Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
1.5 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055608·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127605·2.4 X 22mm Cannulated Headless Screw, T7
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
1.5 LACTOSORB SYSTEM X-PLATE REGULAR
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·December 27, 2019
SPACELABS MEDICAL PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
FDA 510(k)
FDA Class 2
·Dental
PLUM A + DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 3, 2014
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 28, 2011
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 11, 2026
2.0 LACTOSORB SYSTEM STRAIGHT PLATE 4 HOLE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·December 27, 2019
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
FDA Enforcement
Class II
·Ongoing·BioFire Diagnostics, LLC·August 30, 2023
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018