22 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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Full Automatic(NIBP) Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Instrument Tray
FDA UDI
Treace Medical Concepts, Inc.·00810111226745·VPCS Hindfoot Tray
MIXTER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060975·MIXTER FORCEPS MICRO RIGHT ANGLED PARTIAL SERRA...
Metzenbaum Scissors
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896122734·Metzenbaum Scissors Classic Curved Blade S-Shap...
Olympus
FDA UDI
Gyrus ACMI, LLC·00821925045996·nCare 4K Cable Assembly, 1694F, 3G-SDI, 4K BNC ...
ELMED
FDA UDI
ELMED INCORPORATED·00842180102590·BIPOLAR RF-CABLE WITH ELMED (DIN) INSTRUMENT CO...
MODIFICATION TO VIGIL LIPID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KEYSTONE HIP
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 8, 2015
ENDO STITCH*POLYSORB* 2/0 48 VIO DLU SU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code KOG·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·July 1, 2013
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
VISISTAT 35R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code QQS·March 24, 2023
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021