32 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code QAN·November 19, 2021
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Recall
Terminated
·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
FDA Enforcement
Class II
·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·January 12, 2022
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
FDA Recall
Terminated
·Medtronic Inc.·Product code QAN·March 16, 2021
Smith & Nephew Endoscopic Disposable Blades: NOTCHBLASTER ABR,EP-1,5.5 DSPL Part #: 7205329. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code NBH·May 7, 2009
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·May 12, 2021
Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made in Mexico. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510(k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
FDA Recall
Terminated
·Busse Hospital Disposables·Product code EBR·April 13, 2004
Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
FDA Recall
Terminated
·Busse Hospital Disposables·Product code EBR·April 13, 2004
Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code CBR·October 8, 2007
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
FDA Recall
Terminated
·Spacelabs Healthcare Inc·Product code CBR·June 18, 2014
Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. *Tubing Made in Mexico. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
FDA Recall
Terminated
·Busse Hospital Disposables·Product code EBR·April 13, 2004
SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FBR·February 22, 2022
Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code CBR·June 8, 2011
Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1
FDA Recall
Terminated
·The OR Group·Product code FPS·November 6, 2003
Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.
FDA Recall
Terminated
·Cook OB/Gyn, Inc.·Product code HFE·April 2, 2009