12 results · 19ms · Sources: EU EUDAMED, US FDA

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Arthrex SoftStitch

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Bernafon

FDA UDI
Bernafon AG·05714464009572·BERNAFON ALPHA 7 MNR T R MSIL/MAC

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776297053·L Hook Electrode

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112632·BARRON CORNEAL PUNCH 8.0MM

LOFRIC PRIMO, LOFRIC HYDRO-KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SOLA, COUNTER-PULSATION, MODEL SECP-S

FDA 510(k)
FDA Class 2 ·Cardiovascular

1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

PROTEGE RX CAROTID

FDA Adverse Event
Injury ·EV3 INC.·Product code NIM·November 6, 2008

GOBED II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·August 16, 2011

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures

FDA Enforcement
Class II ·Terminated·Acumed LLC·May 7, 2014

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018