22 results · 20ms · Sources: EU EUDAMED, 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