724 results
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93ms
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Sources: EU EUDAMED, US FDA
INTEGRITY MEDICAL PRODUCTS INC
FDA registration
INTEGRITY MEDICAL PRODUCTS INC·2 products·🇺🇸 United States
Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
FDA Enforcement
Class II
·Terminated·Utah Medical Products, Inc·June 19, 2013
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
CORTRAK 2 ENTERAL ACCESS SYSTEM
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·November 3, 2020
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Enforcement
Class I
·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES INC·May 24, 2017
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·October 15, 2014
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·October 15, 2014
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
CORFLO NG/NI FT W/ STYLET & ENFIT
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·December 22, 2022
MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·December 23, 2025
ENFIT PU FEEDING TUBE PURPLE 6.5FR 60CM
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code FPD·April 1, 2026
CM DRIVE ACQUA IMPL TI 4.3X13
FDA Adverse Event
Malfunction
·NEODENT JJGC S.A.·Product code DZE·June 28, 2018
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·February 13, 2020
MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code BTR·January 21, 2020