19 results · 19ms · Sources: EU EUDAMED, US FDA

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HYPERION X5

FDA 510(k)
FDA Class 2 ·Radiology

Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow Meter

FDA UDI
A-M SYSTEMS, LLC·00817081023459·Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow...

Clinician's Choice® High Viscosity Tubes & Plugs

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002240·Dental material injection cannula, single-use

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122254·KWire .062x4" (1.6x100mm)

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702448252·ELVAREX 2/THIGH HIGH/SLANT-CLOSED TOE-ELEPHANTI...

LINEAR? ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 13, 2026

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

PINN CAN BONE SCREW 6.5MMX50MM

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NDJ·July 11, 2011

Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.

FDA Recall
Terminated ·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·September 19, 2018

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·March 8, 2021

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·January 11, 2018

GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE

FDA Adverse Event
Injury ·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019

AIA-900

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·December 14, 2023

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·October 14, 2019

XP-CR Tibial Tray - Interlok 67mm Item # 195271

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019