139 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KDC·June 22, 2004
Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009
Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator, Sterion Inc., Ham Lake, MN; REF 332263. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009
Radionics Disposable Grounding Plate
FDA Recall
Terminated
·Valleylab, Inc·Product code HAM·July 16, 2003
Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
FDA Recall
Terminated
·Valleylab, Inc·Product code HAM·July 16, 2003
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
FDA Recall
Terminated
·ConMed Corporation·Product code HAM·December 27, 2012
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 11, 2019
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 11, 2019
Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 26, 2014
Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 26, 2014
Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 26, 2014
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
FDA Enforcement
Class II
·Terminated·Camlog Usa·September 25, 2013
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
FDA Enforcement
Class II
·Terminated·Talladium Inc·September 16, 2020
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Enforcement
Class II
·Terminated·Sam Medical Products·November 5, 2014
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Enforcement
Class II
·Terminated·Sam Medical Products·March 23, 2022
Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
FDA Recall
Terminated
·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
FDA Enforcement
Class II
·Terminated·Medtronic Xomed, Inc.·October 2, 2013