38 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESPONSE 2000 HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Affiniti
FDA UDI
TORNIER, INC.·00846832022571·LATERAL CUT GUIDE - KNOB
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741091278·Catheter Placement Kit
TEWA
FDA UDI
asia-med GmbH·04251282508562·TeWa 5CB-Type 2015 Speed Pak: coated acupunctu...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501242·TeWa 5CB-Type 2015 Speed Pak: coated acupunctu...
Dexcom G7 Overpatch 10 Pack
FDA UDI
Dexcom, Inc.·00386270004024·Dexcom G7 Overpatch 10 Pack
GeneXpert Dx System
FDA UDI
CEPHEID·07332940004057·XPERT, GENEXPERT DX SYSTEM
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522131363·ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,SHORT,UKCA
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129698·ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,SHORT
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 19, 2025
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 12, 2022
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644465019·
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644465002·
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 12, 2013
I-STAT DOWNLOADER RECHARGER, NETWORK
FDA Adverse Event
Other
·ABBOTT POINT OF CARE INC.·Product code JQP·February 9, 2011
LCS COMP RP INSERT STD+ 12.5MM
FDA Adverse Event
Injury
·DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·February 19, 2008
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 13, 2013
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014