40 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
FDA Recall
Terminated
·US Endoscopy Group Inc·Product code KOG·October 31, 2014
BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
FDA Recall
Terminated
·US Endoscopy Group Inc·Product code OCX·February 17, 2015
UP & UP kids' power toothbrush
FDA Enforcement
Class II
·Terminated·Ranir Corporation·January 29, 2014
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
FDA Enforcement
Class II
·Terminated·Ranir Corporation·January 29, 2014
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
FDA Recall
Terminated
·Kim's Trading Inc·Product code LPM·May 17, 2010
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·June 12, 2013
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
FDA Recall
Terminated
·Cytyc Corporation·Product code KEW·January 29, 2003
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA SCREW 5/PKG***2.0 MM X 7.0 MM***". Bone screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. These screws are to be used with our TMJ (Temporal Mandibular Joint) implants.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code KBW·June 25, 2010
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016
Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·December 2, 2015
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FLE·April 18, 2019
Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·August 4, 2005