25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROSCAN (R) MICROSTREP PLUS (R) PANELS
FDA 510(k)
FDA Class 2
·Microbiology
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·50885380030527·3/5cc Secure Tube
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118319·LOCATOR R-Tx Abutment For 4.25mm Premium Implan...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002356·1.2mm x 5mm Auto-drive Screw
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046841·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112050·Tap, 7.5 mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694030670·1.2mm x 5mm Auto-Drive Screw, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694054492·1.2mm x 5mm Auto-Drive Screw Sterile Qty 10
AAIO-7, AAIO WIRLESS
FDA 510(k)
FDA Class 2
·Ophthalmic
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
FDA 510(k)
FDA Class 2
·Radiology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 14, 2023
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
AUTO LOGIC
FDA Adverse Event
Injury
·GETINGE (SUZHOU) CO. LTD·Product code FNM·April 19, 2013
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 23, 2014
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·May 26, 2011
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013