23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXTENSION SET QUEST CODE #3000
FDA 510(k)
FDA Class 2
·General Hospital
X-Box
FDA UDI
INNO Holdings, Inc.·M71188008250·PEEK, Ta
HEARTLINE RETRACTOR ATRIAL RAKES
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896095762·HEARTLINE RETRACTOR ATRIAL RAKES
ACUMED
FDA UDI
Acumed LLC·10806378045080·2.3mm Long Screw Caddy Base
Arthrex®
FDA UDI
ARTHREX, INC.·00888867042544·4 HOLE DBL COMP PLT,STR,25MM
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
FDA 510(k)
FDA Class 2
·Cardiovascular
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 8, 2014
ALIGN URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·October 17, 2012
SIGMA PS CEM FEM SZ4N R
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2010
DOUBLE COMPRESSION PLATE
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·December 1, 2016
Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614
FDA Recall
Terminated
·Kentec Medical Inc·Product code DQA·May 18, 2007
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
FDA Recall
Terminated
·Kentec Medical, Inc·Product code FPD·January 17, 2020
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021