20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROFIX QUICKANCHOR PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
NSnare
FDA UDI
COOK INCORPORATED·00827002461918·NSnare Stent Retriever
NCompass
FDA UDI
COOK INCORPORATED·00827002327023·NCompass, Nitinol Stone Extractor 3 Wire Basket
NCompass
FDA UDI
COOK INCORPORATED·00827002327009·NCompass Nitinol Stone Extractor
BIGopsy
FDA UDI
COOK IRELAND LTD·10827002482408·BIGopsy Backloading Biopsy Forceps
NCompass
FDA UDI
COOK INCORPORATED·00827002327016·NCompass, Nitinol Stone Extractor 4 Wire Basket
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556879832·HUMERAL HEAD 41MM X 15MM CONCENTRIC
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
FDA 510(k)
FDA Class 2
·Anesthesiology
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NCompass
FDA UDI
COOK INCORPORATED·00827002328631·NCompass, Nitinol Stone Extractor 4 Wire Basket...
NCircle
FDA UDI
COOK INCORPORATED·00827002191105·NCircle, Nitinol Tipless Stone Extractor Delta ...
CAPIOX HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016
NEEDLE 18X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·November 6, 2023
NCircle
FDA UDI
COOK INCORPORATED·00827002191112·NCircle, Nitinol Tipless Stone Extractor Modifi...
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·March 27, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 11, 2011
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·April 5, 2008
CAPIOX RX OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024
TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·April 10, 2023
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012