21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
25GA Curved Illuminating Probe, SMA906
FDA UDI
Peregrine Surgical, Llc·00632307001826·25GA Curved Illuminating Probe, SMA906
25LB CLEAR POLYMER
FDA UDI
Great Lakes Dental Technologies, Ltd.·D7750400180·25LB CLEAR POLYMER
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935106807·
N/A
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327500523·Patient Tracker Advanced
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710300400180·Tibial Osteotmy Guide, 40mm x 18mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310400180·Talar Osteotmy Guide, 40mm x 18mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820400180·Zadik Calcaneal Guide, 40mm x 18°
CONTOUR CURVED CUTTER STAPLER CS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006
SKINGARD POLYCOAT GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
BRANEMARK NOVUM
FDA 510(k)
FDA Class 2
·Dental
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
FDA Recall
Terminated
·Cook Inc.·Product code KOB·April 22, 2019
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 29, 2019
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
INFUSE BONE GRAFT DEVICE (RHBMP-2)
FDA Adverse Event
MEDTRONIC INC.·Product code NEK·April 3, 2013
MAHURKAR MAXID 23 CM
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FJS·March 25, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·May 7, 2008
SALLE PYELOPLASTY STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 27, 2017