14 results · 19ms · Sources: EU EUDAMED, 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