25 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PicoSure Workstation
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTHRO-PIERCE
FDA UDI
Smith & Nephew, Inc.·03596010601377·MTO ARTHRO-PIERCE INSTR 45 L
DG Gel 8 Anti-c
FDA UDI
DIAGNOSTIC GRIFOLS SA·08436583731079·For the determination of human c antigen on the...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721926·Sheehan Osteotome 6-1/4" (15.6cm), 15mm wide, h...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515036390·Stille Osteo, str, 10mm, 6 1/4"
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 24, 2022
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 24, 2022
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
VERDICT -II METHAMPHETAMINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 8, 2022
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020
RELIANCE 4-FRONT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·February 3, 2022
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 11, 2011
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 20, 2008
2124215-2013-06838
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVN·July 8, 2013
FLEXTEND
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DTB·July 15, 2025
ATTUNE PS RP INSRT SZ8 6MM
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code NJL·March 14, 2025
SKINTACT
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·January 13, 2022
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023