14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXCUT CARBIDE BUR (100/pk) FGSS 8
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119861·MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size:...
Relief Pak 24 pack heating Unit mobile
FDA UDI
KARIS Co.,Ltd·08809520550574·It is a device intended for medical purposes th...
Relief Pak 24 pack heating Unit
FDA UDI
KARIS Co.,Ltd·08809520550253·It is a device intended for medical purposes th...
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SAFE-STEER GUIDE WIRE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VITEK® 2 AST-ST01 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·October 24, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
EBI MODEL 10D
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 9, 2022
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021