2,678 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OT EQUATOR
FDA UDI
RHEIN 83 SRL·08059224205403·Set of devices intended to be incorporated into...
Instrument
FDA UDI
Stanmore Implants Worldwide Ltd·05060296236434·Base - Small Customs Tray
Instrument
FDA UDI
Stanmore Implants Worldwide Ltd·05060296236441·Insert - Small Customs Tray
ENDOPATH*PROBE PLUS II SHAFT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2020
Phoenix Key Tie
FDA UDI
PHOENIX ORTHODONTICS INC·05060772894080·KEY TIE SMOKE PK1000
BD PRECISIONGLIDE¿ 27 G X 1/2" HYPODERMIC NEEDLES
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 1, 2023
200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code HAW·July 17, 2009
System, Test, Combs, Automated
FDA classification
FDA Class 2
·System, Test, Combs, Automated
CSM Implant
FDA registration
CSM Implant·3 products·🇰🇷 South Korea
GSM, LLC
FDA registration
GSM, LLC·1 product·🇺🇸 United States
DSM Biomedical, Inc.
FDA registration
DSM Biomedical, Inc.·29 products·🇺🇸 United States
DSM HOLDINGS CO., LTD
FDA registration
DSM HOLDINGS CO., LTD·1 product·🇰🇷 South Korea
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA
FDA 510(k)
FDA Class 2
·Immunology
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
K-2SM SmartMatt
FDA UDI
KAP MEDICAL·00817012029376·Auto Immerssion, Alternating Pressure with On-D...
K-2SM SmartMatt
FDA UDI
KAP MEDICAL·00817012029345·Auto Immerssion, Alternating Pressure with On-D...
K-2SM SmartMatt
FDA UDI
KAP MEDICAL·00817012029369·Auto Immerssion, Alternating Pressure with On-D...
K-2SM SmartMatt
FDA UDI
KAP MEDICAL·00817012029307·Auto Immerssion, Alternating Pressure with On-D...
K-2SM SmartMatt
FDA UDI
KAP MEDICAL·00817012030563·Alternating Pressure, Auto Immersion, On-Demand...
K-2SM SmartMatt
FDA UDI
KAP MEDICAL·00817012029338·Auto Immerssion, Alternating Pressure with On-D...