18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAM-200
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777457·LUMBAMED PLUS FLEX PAD WM SILVER III
ARGENCO BIO 1 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120243·Gold based noble metal
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007492·SOSOFT 8-15 MM HG KNEE HIGH BROCADE SMALL WHITE...
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·50822383729157·Bath SafetyGrab Bars Product Description: GrabB...
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·00612479224292·Bath SafetyGrab Bars Product Description: GrabB...
ATELLICA CH 930 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CEK·August 11, 2023
QUINTEX CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LASERPRO 16
FDA 510(k)
FDA Class 2
·Radiology
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEK·March 10, 2023
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013
XENMATRIX
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTM·May 31, 2011
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 14, 2008
ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CEK·August 14, 2023
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024