15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BRONCHO-FIBERSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SOL-M™ Luer Lock Syringe with Exchangeable Needle
FDA UDI
Sol-Millennium Medical, Inc.·00818392011586·Used to inject medicines and vaccines into, or ...
DD cube ONE ML
FDA UDI
Dental Direkt GmbH·EDDIG8320101·DD cube ONE® ML are dental mill blanks made fro...
LEONE SPA
FDA UDI
LEONE SPA·08033707066804·ELASTIC LIGATURES TRANSP 1,0mm
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153639·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153646·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153653·
VIDAS C DIFFICILE GDH
FDA 510(k)
FDA Class 1
·Microbiology
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 30, 2020
46 ELEV.
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code EMJ·March 7, 2014
ASR UNI FEMORAL IMPL 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2015
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021