11 results
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18ms
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Sources: EU EUDAMED, US FDA
LUKENS STAINLESS STEEL SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Navina Mini Refill Set
FDA UDI
Wellspect AB·07333387052779·Navina Mini Refill Set. 30 Rectal Cones. Non St...
Barco
FDA UDI
Barco NV·05415334001855·MDSC-8358 RLG
KYMCO EQ20C SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
NOMAD ND1000M AUGMENTED VISION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 16, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013
PLATE, FXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·July 13, 2014
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·February 25, 2026