17 results
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17ms
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Sources: EU EUDAMED, US FDA
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PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TUBE SUCTION CONNECT. }4" X 12' LIF (1) SURGICAL BLADE #11 CARBON STEEL (1 ELASTIC BANDAGE 6" X 5 YRD. L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 28, 2016
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 28, 2016
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·February 28, 2018
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·September 3, 2025
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 24, 2024
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
FDA Enforcement
Class II
·Terminated·Allen Medical Systems·February 28, 2018
Comprehensive Mini Stem, Item No. 113631:
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 19, 2018
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 19, 2018
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025