20 results · 25ms · 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.

EXPEDIO 500D R&F X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040009338·Zirlux 16+ G2 coloring liquid

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780767·LEVAMED ACTIVE ANKLE SUP SLVR L IV

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526189737·LEVAMED ACTIVE ANKLE SUP BLACK L IV

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112240·Tap, 6.50mm, Cannulated, Fixed Sleeve

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 4, 2026

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 14, 2026

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 10, 2025

CYBERKNIFE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

FDA 510(k)
FDA Unclassified ·Unknown

10 ML FILL IN 10 ML DIAMETER BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE

FDA Adverse Event
Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·November 14, 2016

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 19, 2025

MINIMED QUICK-SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 22, 2025

HDI 5000 ULTRASOUND STANDARD SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

NEUROFORM 3 EZ 3.5 X 20MM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORK, LTD·Product code NJE·March 19, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·March 9, 2011

CATH PKGD: BERMAN 5 FR 5 0CM

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DQO·March 10, 2008

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20

FDA Enforcement
Class II ·Ongoing·Biocare Medical, LLC·November 13, 2024

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012