30 results · 32ms · 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.

INTERVENTIONAL BODY COIL

FDA 510(k)
FDA Class 2 ·Radiology

PowerPICC

FDA UDI
Bard Access Systems, Inc.·00801741102905·Catheter Placement Kit

Councill Stylet

FDA UDI
C. R. Bard, Inc.·00801741049019·Councill Stylet

Synergy™ Ablation System

FDA UDI
ATRICURE, INC.·10840143900020·Glidepath Tape (3-Unit)

TEWA

FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502294·TeWa CJ-Type 1630: coated acupuncture needles ...

TEWA

FDA UDI
asia-med GmbH·04251282509613·TeWa CJ-Type 1630: coated acupuncture needles ...

Synergy™ Ablation System

FDA UDI
ATRICURE, INC.·00818354010718·Glidepath Tape (3-Unit)

LIFEPAK® 12 defibrillator/monitor

FDA UDI
PHYSIO-CONTROL, INC.·00721902149115·LP12AABBABAABBABAAAAAAAALP12 MONITOR-DEFIB

UniTip Catheter

FDA UDI
Unisensor AG·07640172971529·

MONOFILAMENT BIOSYN SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ENHANCED COMPENSATING FILTER

FDA 510(k)
FDA Class 2 ·Radiology

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 4, 2023

SPINNING SPIROS CLOSED MALE LUER, RED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·February 2, 2021

FREESTYLE FREEDOM LITE

FDA Adverse Event
Injury ·Product code NBW·August 13, 2010

CAST CUTTER, 8 FOOT CORD "

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAB·March 12, 2013

TALENT ABDOMINAL EXTENSION CUFF

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·February 21, 2008

SPINNING SPIROS CLOSED MALE LUER, RED CAP

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·February 10, 2021

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013