231 results
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Sources: EU EUDAMED, US FDA
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I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LXH·September 12, 2018
PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
FDA Recall
Terminated
·Pml Microbiologicals Inc.·Product code JSO·August 17, 2007
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
FDA Recall
Terminated
·CTL Medical Corporation·Product code MNI·July 5, 2018
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA Recall
Terminated
·CTL Medical Corporation·Product code NKB·July 5, 2018
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
FDA Recall
Terminated
·Pml Microbiologicals Inc.·Product code JSO·April 23, 2007
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SM_40HF_B_D_VIR3, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SM_40HF_BDC3, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025