43 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Axcent Acrylics
FDA UDI
GARRECO, LLC·D79331004050·Premium Lt Char 5lb
Bur PM2-70 80K Carb Ø7.0 St
FDA UDI
Bien-Air Surgery SA·17630055503692·
Digital Analogue RP
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074376·
WizardBio Resorbable Calcium Phosphate Cement
FDA UDI
DSM BIOMEDICAL, INC.·M263W25000·WizardBio Resorbable Calcium Phosphate Cement
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989027037·TMA BROAD ARCH UP SML 0210 0250 PK/10
GLOVER COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004050·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED STRAIGHT
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 28, 2025
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
FDA 510(k)
FDA Class 2
·Radiology
INTERCURE LTD. RESPI-LOW
FDA 510(k)
FDA Class 2
·Neurology
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
PT²?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011
BACT/ALERT MP - 419744
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 5, 2019
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·March 29, 2021
Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYG·May 25, 2005
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
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