28 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SpheRx
FDA UDI
Nuvasive, Inc.·00887517443533·SpheRx® II Lamina Hook, 8mm Ext Narrow
MaXcess
FDA UDI
Nuvasive, Inc.·00887517197603·MaXcess 4 Blade, 120mm Left
TETRIS 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844023068·The basic shape of the KIMBA®, KIMBA® mini, MOB...
TETRIS 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844002285·The basic shape of the KIMBA®, KIMBA® mini, MOB...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704515183·
Sklar
FDA UDI
SKLAR CORPORATION·10649111442568·CHILDE SUTURE FORCEPS 7 IN
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 12, 2023
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78824112000201·EXRC MBT 018/UR2 10T 8A
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981030216·Screw Offset - Closed, 20mm
Sochi
FDA UDI
Altus Spine, LLC·00843210168081·Screw Offset, Closed, 20mm
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EV APAN DIGITAL, MODEL K1VSM2000
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
LUMAX 340 VR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·July 22, 2013
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·April 30, 2025
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020