31 results
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20ms
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Sources: EU EUDAMED, US FDA
SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117682·Nobel Tri-Lobe NP x 4.5mm Non-Engaging Titanium...
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741101595·Catheter Placement Kit
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502652·TeWa CJ-Type 2530: coated acupuncture needles ...
TEWA
FDA UDI
asia-med GmbH·04251282509972·TeWa CJ-Type 2530: coated acupuncture needles ...
ESU Shroud
FDA UDI
I.C. MEDICAL, INC.·00817688021971·
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
FDA 510(k)
FDA Class 2
·Dental
SUNI MAX
FDA 510(k)
FDA Class 1
·Dental
SMR GLENOID BASEPLATE STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·June 29, 2022
SINGLE USE DISTAL COVER
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code FDT·October 16, 2024
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 12, 2013
MEDTRONIC ANEURX STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011
PUMP MMT-715NAB PRDGM INS V2.1 BL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·February 21, 2008
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
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
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·October 1, 2014
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016