17 results · 29ms · Sources: EU EUDAMED, US FDA

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ACUSON S1000 / S2000 / S3000

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814558·GENUMEDI SAND SIZE IV

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011132804000·Grinding points, pink, medium hardness, medium ...

SPI TITANIUM BASE FOR CAD/CAM

FDA 510(k)
FDA Class 2 ·Dental

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

SUR-FIT 2 PC DURAHESIVE MOLDABLE WAFER

FDA Adverse Event
Injury ·CONVATEC, INC.·Product code EXE·September 29, 2014

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·June 17, 2011

INSTINCT ENDOSCOPIC HEMOCLIP

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code PKL·July 19, 2021

INSTINCT ENDOSCOPIC HEMOCLIP

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

PEDICLE SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

PEDICLE SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

Stockert 70 Radio Frequency Ablation Generator

FDA Recall
Terminated ·Biosense Webster, Inc.·Product code DRF·July 16, 2004

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024