9 results
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6ms
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Sources: EU EUDAMED, US FDA
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·July 25, 2012
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·September 26, 2012
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 28, 2018
GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·July 17, 2013
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·September 7, 2016
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·December 9, 2015
Drop Arm Versamode"
FDA Enforcement
Class II
·Terminated·Gf Health Products·April 14, 2021
Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc·December 21, 2016
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
FDA Enforcement
Class II
·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014