124 results
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26ms
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Sources: EU EUDAMED, US FDA
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NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·July 30, 2014
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·October 17, 2012
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·October 17, 2012
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·August 1, 2012
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
FDA Enforcement
Class II
·Ongoing·Cypress Medical Products LLC·September 25, 2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
FDA Enforcement
Class II
·Ongoing·Cypress Medical Products LLC·September 25, 2024
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 7, 2020
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·July 27, 2022
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
FDA Enforcement
Class II
·Terminated·Mortara Instrument, Inc·June 24, 2015
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
FDA Enforcement
Class II
·Terminated·MicroAire Surgical Instruments, LLC·April 13, 2016
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
3-Way Standardbore Stopcock. Product Code: AMS-100.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·December 27, 2017
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
FDA Enforcement
Class II
·Terminated·SIE AG, Surgical Instrument Engineering·April 4, 2018
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·June 10, 2026