30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004066·PowerChem Neoprene Exam Gloves, Extra Extra Large
OPTIMIZER
FDA UDI
Conmed Corporation·10653405053507·CONMED OPTIMIZER Polypectomy Snare; Extra Small...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282503130·TeWa CJ-Type 2525 (s): uncoated acupuncture ne...
TEWA
FDA UDI
asia-med GmbH·04251282510459·TeWa CJ-Type 2525 (s): uncoated acupuncture ne...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004660·
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688020141·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004660·
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ENDOSCOPIC CO2 REGULATION UNIT
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code HIF·November 22, 2024
MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWQ·September 18, 2000
MEDFUSION 4000 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FRN·July 18, 2025
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 11, 2014
ZENITH AAA MAIN BODY GRAFT
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·February 21, 2008
MARA WATER VAPOR PROBE KIT
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code MNB·September 29, 2023
LEEP PRECISION GENERATOR
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·October 25, 2023
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015