21 results · 23ms · Sources: EU EUDAMED, US FDA

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POWERLOC CLEAR SAFETY INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

AART SILICONE TUBING

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

AUDIOSCAN VERIFIT, MODEL VF-1

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

SYMBIA T-SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013

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·November 4, 2025

E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

FDA Adverse Event
Injury ·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012

E.CAM, SYMBIA E

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012

E.CAM, SYMBIA E

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013

E.COM, SYMBIA E

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012

E.CAM

FDA Adverse Event
Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2013

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·May 9, 2011

DUAL CUT SAGITTAL BLADE

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS CORK·Product code GFA·July 29, 2008

E.CAM, SYMBIA E

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 11, 2026

Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP

FDA Recall
Terminated ·Haemonetics Corporation·Product code CAC·December 21, 2005

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014