29 results
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13ms
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Sources: EU EUDAMED, US FDA
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
FDA Recall
Terminated
·Philips Visicu·Product code DRG·March 10, 2016
Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010
FDA Recall
Terminated
·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010
Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010
AUTION HYBRID AU-4050
FDA Recall
Terminated
·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 12, 2021
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 12, 2021
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·October 12, 2021
Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HNO·June 8, 2007
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
FDA Recall
Terminated
·Invacare Corporation·Product code INO·June 18, 2013
DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)
FDA Recall
Terminated
·Diasorin Inc.·Product code JNO·February 15, 2007
ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.
FDA Recall
Terminated
·Med-logics Inc·Product code HNO·January 13, 2015
Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HNO·April 23, 2008
Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HNO·April 23, 2008
Lift Chairs. Electric Positioning Chair.
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code INO·June 7, 2004
Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HNO·June 8, 2007
Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
FDA Recall
Terminated
·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017
EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
FDA Recall
Terminated
·Altimate Medical, Inc.·Product code INO·October 4, 2022
WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.
FDA Recall
Terminated
·Wavelight AG Industriegebiet Doellnitz 5 Pressath Germany·Product code HNO·April 18, 2011