28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Synergy Vision Endoscopic Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sonic
FDA UDI
Sbo Hearing A/S·05714464089741·SONIC ENCHANT SE 10 MNR BE/TP
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D9092507281·.016 X .016 SS UTILITY ARCHES 28MM (5)
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
aap Implantate AG·04042409445224·Cannulated Headless Bone Screw 2.5, L 28, TL 7 ...
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 12, 2011
QUICKSET 1PC FLEX DRILL BIT 35
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·December 2, 2008
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN FORMERLY TISSUE·Product code FTL·July 19, 2013
TELEGRAPH®
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489507281·
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
MAVERIC MEDICAL LLC
FDA Adverse Event
Malfunction
·ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.·Product code KST·April 14, 2026
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·January 13, 2026
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·October 26, 2022
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·October 26, 2022
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·October 26, 2022
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·October 26, 2022
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020