24 results · 22ms · 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.

Intraluminal Applicator Set

FDA 510(k)
FDA Class 2 ·Radiology

AGC Tradition Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304002470·

HHM

FDA UDI
Oticon A/S·05707131282828·H110V2, BTE 13 WL 100 SIL HHM

electrodeCUR

FDA UDI
COSMAN MEDICAL, LLC·08132500164134·Electrode 15cm, 10mm Tip, 22G

Ni-Lock® Anterior Cervical Plate System

FDA UDI
Spine Wave, Inc.·10840642102901·Plate 22mm 1 Level

electrodeCU

FDA UDI
COSMAN MEDICAL, LLC·08132500161614·Electrode 15cm, 10mm Tip, 22G

N/A

FDA UDI
Smith & Nephew, Inc.·00817470009019·15 DEG. PICK

VARIANT

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1510220·Threaded Fixation Pin, ø3mm x 220mm

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·May 30, 2018

PULMOTRACK 5050 WHOLTER, MODEL 5050

FDA 510(k)
FDA Class 2 ·Cardiovascular

GAMMAPLAN

FDA 510(k)
FDA Class 2 ·Radiology

LCCS

FDA UDI
LCCS Products Limited·04895233602222·Single-use RF Cannula

MENTOR SILTEX CONTOUR PROFILE HIGH

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·February 3, 2020

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 6, 2013

STANDARD INSERT

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·June 29, 2011

FREESTYLE FREEDOM LITE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC. USA·Product code LFR·August 29, 2008

MENTOR SILTEX CONTOUR PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·August 1, 2018

MENTOR SILTEX CONTOUR PROFILE HIGH

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·April 1, 2019

XCELA

FDA Adverse Event
Malfunction ·PFM MEDICAL CPP SA·Product code LJT·November 7, 2023

Biograph mMR. Model Number: 10433372.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025