13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RALCO
FDA 510(k)
FDA Class 2
·Radiology
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108564·SENSIFOOT 8-15 MM HG KNEE HIGH SMALL BROWN 1 EN...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819070·3.5cm x 10 cm Loughlin-Simpson Retractor
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED
FDA 510(k)
FDA Class 1
·General Hospital
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 4, 2022
LAMITRODE S8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 2, 2011
REVITAN, RASP, DISTAL, CURVED, 14/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 11, 2018
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025