18 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing

FDA 510(k)
FDA Class 2 ·Orthopedic

Leg Bag

FDA UDI
C. R. Bard, Inc.·00801741050923·Dispoz-A-Bag Leg Bag, Large (32oz), with Flip-F...

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

FDA 510(k)
FDA Class 2 ·Radiology

IGLUCOSE SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ZOLL IVTM COOL LINE CATHETER

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION·Product code NCX·August 21, 2021

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

CARELINK

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·August 17, 2022

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025