63 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
FDA Enforcement
Class II
·Terminated·Integra Lifesciences Sales Llc·December 25, 2019
Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
FDA Recall
Terminated
·Integra Lifesciences Sales Llc·Product code KYJ·November 4, 2019
Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code ---·October 31, 2002
Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Ascension Orthopedics, 8700 Cameron Road, Suite 100, Austin, Texas 78754; TEL: 512 836-5001. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis.
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code NEG·June 17, 2009
Ascension PIP instrument tray base, manufactured by Ascension Orthopedics, Austin, Texas
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code NEG·October 2, 2003
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
FDA Enforcement
Class II
·Terminated·In2Bones, SAS·April 1, 2015
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
FDA Enforcement
Class II
·Terminated·In2Bones, SAS·April 1, 2015
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·June 26, 2012
Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Enforcement
Class I
·Terminated·Biomerieux·December 30, 2015
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
FDA Recall
Terminated
·In2Bones, SAS 28 Chemin Du Petit Bois Ecully France·Product code HWC·March 9, 2015
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
FDA Recall
Terminated
·In2Bones, SAS 28 Chemin Du Petit Bois Ecully France·Product code HWC·March 9, 2015
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Enforcement
Class I
·Terminated·Biomerieux·December 30, 2015
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Enforcement
Class I
·Terminated·Biomerieux·December 30, 2015
Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDW·January 23, 2009
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 2, 2013
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·November 19, 2015
Etest PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·November 19, 2015
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
FDA Recall
Terminated
·Biomerieux 69280 Marcy Letoile France·Product code JWY·November 19, 2015
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003
IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003