42 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FETAL MONITOR MODEL: BT-200T
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964062551·Endo Carry-On Procedure Kit
NITANIUM® ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707065690·.018 Lower Coated Nitanium® Pro Form™ Archwires
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 30, 2018
MAXCUT DIAMOND BURS (6/pk) MED 885-012
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100885121·MAXCUT DIAMOND BURS (6/pk) Shape: Pointed Cylin...
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047459·
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047510·
Zavation
FDA UDI
Zavation LLC·00197157002251·8.5mm Cannulated Tap
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047534·
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047497·
Monoblock Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043674·
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047473·
UNI-LASER 470
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRX HBA1C - FOR PRESCRIPTION HOME USE
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 12, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 24, 2011
AUTOMATED PD SET W/CASSETTE 4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FKX·August 6, 2008
Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019