39 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Bur PM2-95 80K steel Ø1.0mm sterile
FDA UDI
Bien-Air Surgery SA·J00711004460011·
Bur PM2-95 80K Steel Ø1.0 St
FDA UDI
Bien-Air Surgery SA·17630055504019·
Digital Analogue 4.3
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074758·
Osstell SmartPeg Type 35
FDA UDI
Osstell AB·09010522001462·ISQ Measurement Peg
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044610001·Dowel Pin 12 mm
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 29, 2025
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
FDA 510(k)
FDA Class 2
·Cardiovascular
EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 8, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·September 19, 2014
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 13, 2011
Lower Extremity Pack, part number AMS4669
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016
Brilliance iCT (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