23 results · 21ms · Sources: EU EUDAMED, 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