24 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257141113·15-20 MFW VITALITY CALF CT CHARC V
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735480·Cuticle Scissors 3-1/2" (8.8cm), curved blades,...
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291105435·SS Suture, 5 per sleeve
NA
FDA UDI
Conmed Corporation·30653405038751·5MM X 43CM ENDOWEAVE TIP MONOPOLAR DISSECTOR
Toilet Support Arms
FDA UDI
Ropox A/S·05707581004261·
K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER
FDA Adverse Event
Malfunction
·Product code LXH·November 2, 2021
WOUND PROTECTOR/RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHILIPS BV PULSERA/ENDURA
FDA 510(k)
FDA Class 2
·Radiology
K-WIRE GAMMA Ø3,2X450 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·April 22, 2022
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400404350·C & B FORMULA 4 OZ SHADE 35
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 28, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·February 27, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 1, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NDN·February 27, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 8, 2013
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·April 5, 2011
HI LO EVAC
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCO·Product code BTR·May 7, 2008
ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-435. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
FDA Recall
Terminated
·Conmed Corporation·Product code GCJ·October 12, 2006
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013