11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Safety Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL™ Brain Heart Infusion Broth
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902217788·Tube BHI Broth 0.5 Ml 100 Ea
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
FDA 510(k)
FDA Class 2
·Cardiovascular
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
TRIDENT 0° CROSSFIRE INSERT 36 MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·November 3, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 17, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·July 9, 2013
BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** 800-638-8663 A general purpose liquid medium used for the cultivation of bacteria employed in the preparation of inocula for microdilution minimal inhibitory concentration (MIC) and identification (ID) tests.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code KZI·February 19, 2009
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018