362 results
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73ms
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Sources: EU EUDAMED, US FDA
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC·Product code LPB·September 21, 2017
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
FDA Enforcement
Class II
·Terminated·Progressive Medical Inc·November 21, 2012
THERMOCOOL SMARTTOUCH SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·September 22, 2017
HISTOACRYL TISSUE ADHES.TRNS 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·February 23, 2016
ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·March 29, 2018
Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
DURAMATRIX-ONLAY
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code GXQ·December 12, 2025
Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006
Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number: 70890655 Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to protect surgical microscopes from contamination during various procedures. Labeling for the product is as follows: (1.) INNER CARTON LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)30748426064206, (17) 150700(10) DA102032, INNER, Rev. C. (2.) PRODUCT LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 1, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01) 00748426064205, (17) 150700(10) DA102032, EACH, Rev. D. (3.) CARTON LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12/CS, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)50748426084200, (17) 150700(10) DA102032, INNER, Rev. D.
FDA Recall
Terminated
·Microtek Medical, Inc.·Product code KKX·August 23, 2010
OSSEOGUARD MEMBRANE
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPL·December 15, 2025
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 31, 2012
OSSEOGUARD FLEX
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPL·December 12, 2025
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·KANAE CO., LTD.·Product code KDJ·July 17, 2011
THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·September 14, 2018
X-TRA TRACTION SHOE COVER BLUE UNIV
FDA Adverse Event
Injury
·O&M HALYARD, INC·Product code FXP·June 23, 2025
X-TRA TRACTION SHOE COVER BLUE UNIV
FDA Adverse Event
Injury
·O&M HALYARD, INC.·Product code FXP·June 23, 2025
69252 X-TRA TRACTION SHOE COVER BLUE UNIV
FDA Adverse Event
Injury
·O&M HALYARD, INC.·Product code FXP·June 23, 2025