22 results
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12ms
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Sources: EU EUDAMED, US FDA
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
FDA Recall
Terminated
·Zimmer, Inc.·Product code KRR·July 30, 2014
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRR·January 11, 2016
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code HRY·December 21, 2017
IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DXJ·October 21, 2009
Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009
Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009
KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm
FDA Recall
Terminated
·Eastman Kodak Co·Product code IXJ·April 8, 2005
Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001
FDA Recall
Terminated
·Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom·Product code HXJ·May 17, 2006
IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
FDA Recall
Terminated
·Philips Medical Systems·Product code DXJ·March 4, 2008
Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DXJ·May 5, 2009
CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
FDA Recall
Terminated
·Philips Medical Systems·Product code DXJ·March 4, 2008
Ultraview Universal Clinical Workstation System Model 90385.
FDA Recall
Terminated
·Spacelabs Medical Incorporated·Product code DXJ·January 7, 2005
Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009
Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DXJ·July 8, 2011
Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DXJ·October 19, 2010
Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
FDA Recall
Terminated
·Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom·Product code HXJ·May 17, 2006
Spacelabs flat panel monitor, Model 91415-A
FDA Recall
Terminated
·Datex-Ohmeda, Inc.·Product code DXJ·October 29, 2003
The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code DXJ·October 23, 2009
CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DXJ·May 5, 2009