16 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINEAR HIP STEM, SIZE 5
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I
ARGENCO 83 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120241·Gold based noble metal
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007461·SOSOFT 8-15 MM HG KNEE HIGH BROCADE MEDIUM SAND...
RAPIDSystems™ AutomaticQC Cartridge
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414465883·For in vitro diagnostic use for multi-level qua...
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
FDA 510(k)
FDA Class 2
·Anesthesiology
QACA IGG/IGM ELISA KIT
FDA 510(k)
FDA Class 2
·Immunology
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
TGS UKA FEMORAL AND TIBIAL COMPONENTS
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·June 10, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·February 11, 2020
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·February 11, 2020
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