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

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DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER

FDA 510(k)
FDA Class 3 ·Orthopedic

Malecot

FDA UDI
COOK INCORPORATED·00827002146457·Percutaneous Malecot Nephrostomy Catheter Set

3D ENDOSCOPE

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

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER

FDA 510(k)
FDA Class 2 ·Anesthesiology

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 21, 2025

ASR ACETABULAR IMPLANT 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

TRABECULAR METAL FEMORAL STEM PRESS FIT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code LPH·May 3, 2011

ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·July 25, 2008

BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·December 22, 2021

BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·November 3, 2021

BD POSIFLUSH¿ NORMAL SALINE SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·December 9, 2021

A7 ANESTHESIA SYSTEM

FDA Adverse Event
Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018