792 results
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18ms
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Sources: EU EUDAMED, US FDA
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MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
FDA Enforcement
Class II
·Terminated·Stryker Craniomaxillofacial Division·February 18, 2015
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Acumed LLC·March 22, 2017
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·March 9, 2022
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·August 22, 2018
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Enforcement
Class II
·Terminated·Arrow International Inc·March 6, 2019
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
CLARITY II Laser System; Model No. 1110200210.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·March 18, 2026
Genesis Push-In Suture Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Biocomposite Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026