45 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILK NONABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Nobel
FDA UDI
Preat Corporation·00842092139493·Titanium Scan Body for Nobel Tri-Lobe RP
Sledgehammer
FDA UDI
Keystone Industries·H66810005411·SC 25 lb Pwd & 4 Qt Liq Kit, Lt Fibered
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741105159·Catheter Placement Kit
PerFuse™ Percutaneous Decompression System
FDA UDI
Biomet Orthopedics, LLC·00887868263026·
PERFUSE
FDA UDI
Biomet Biologics, LLC·00880304999602·
intellijoint KNEE®
FDA UDI
Intellijoint Surgical Inc·00628184005415·Camera Mount
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688022015·
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 4, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2024
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 9, 2025
ULTRASONIC IMAGING CATHETER - CORONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·March 12, 2013
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 24, 2011
COMBO
FDA Adverse Event
Malfunction
·STRYKER SPINE BRDEAUX·Product code KWQ·February 15, 2008
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
FDA Recall
Terminated
·Biomet, Inc.·Product code FMF·April 11, 2016
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code QJR·November 5, 2024
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 1, 2016
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code LLZ·May 18, 2007