25 results · 21ms · Sources: EU EUDAMED, 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