67 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vial Adapter
FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108240528·Vial Adapter 20mm ML SIL - VF
Cook
FDA UDI
COOK INCORPORATED·00827002141735·Fascial Dilator
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023010·
Optimus Drill Q - 3.5mm 30mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215058272·
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
FDA 510(k)
FDA Class 2
·Microbiology
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 24, 2020
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 7, 2024
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·October 8, 2024
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 22, 2013
PROPAQ MD DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 20, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
SYRINGE 20ML LL S/C 48
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·July 31, 2024
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·November 13, 2024
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
FDA Enforcement
Class II
·Terminated·Pyng Medical Corporation·November 11, 2015
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
FDA Enforcement
Class II
·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·June 15, 2022
Vaginal Delivery, ASDV25B; Medical convenience kit
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code MLS·August 7, 2024