16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U2 Femoral Component, CR, Porous Coated, Additional Sizes
FDA 510(k)
FDA Class 2
·Orthopedic
Leg Bag
FDA UDI
C. R. Bard, Inc.·00801741050886·Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Va...
Oticon
FDA UDI
Oticon A/S·05707131280893·H16V2, BTE 13 WL 100 SIL
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869607698·TELIX K Ti Cage 8x32mm 5°
FORTEX PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEG BAG
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code FAQ·August 4, 2025
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·October 8, 2014
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·June 6, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021
Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures, with the addition of STERIS table accessories. Tabletop positioning and articulations are controlled via the hand control.
FDA Recall
Terminated
·Steris Corp·Product code FQO·May 12, 2009
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024