17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTRICITY PACS
FDA 510(k)
FDA Class 2
·Radiology
Shiley
FDA UDI
Covidien LP·40884521068224·Evac Oral Tracheal Tube Seal Guard, Murphy Eye
Mallinckrodt
FDA UDI
Covidien LP·10884521068223·Evac Oral Tracheal Tube,Seal Guard, Murphy Eye
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108755·SENSIFOOT 8-15 MM HG MINI CREW EXTRA SMALL WHIT...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819285·Simpson-Wylie Vein Retractor 1" x 7"
HYCARE LATEX EXAMINATION GLOVE, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
CEROX, MODEL 321OF
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 6, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
LOGIC TIBIA PS MOD INSRT SZ 6 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 17, 2023
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
ENDOVIVE? JEJUNAL FEEDING TUBE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·September 23, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024