15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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