27 results · 24ms · Sources: EU EUDAMED, US FDA

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OncoMate MSI Dx Analysis System

FDA 510(k)
FDA Class 2 ·Immunology

7000 CONNECTORS

FDA UDI
HANS RUDOLPH, INC.·00817136022154·CONN 35IDORG X 25.4IDORG 7000

Cut Guide

FDA UDI
Treace Medical Concepts, Inc.·00810111222051·MTA Stepped Cut Guide

GERALD FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060128·GERALD FORCEPS STRAIGHT TEETH

Initia Total Hip System

FDA UDI
KYOCERA CORPORATION·04547898306280·STD LINER 32-56/58

Initia Total Hip System

FDA UDI
KYOCERA MEDICAL CORPORATION·04580810057983·"STD LINER 32-56/58 Size:32-56/58 Type:Flat 32m...

Ortho Organizers

FDA UDI
Ortho Organizers, Inc.·00190707040802·MOSQUITO FORCEPS- 1/2" FINE TIP

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

FDA 510(k)
FDA Class 2 ·Cardiovascular

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962160275·NANO PLASTIC TRAY, 7"X2"X3 1/2", W/SILICONE MAT

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 29, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2016

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 10, 2011

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2008

FF 360

FDA Adverse Event
Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code GAT·July 1, 2013

MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·March 8, 2024

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·September 29, 2021

iCT SP (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

ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

FDA Enforcement
Class II ·Terminated·Abbott Laboratories, Inc·March 13, 2019