21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Konicaminolta DI-X1
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Sensi-Disc™ Oxacillin 1 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902309062·BD BBL™ Sensi-Disc™ Oxacillin 1 µg
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318164·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY...
PQ Autoclave Pouches (3-1/4" x 12") Clear Film
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724P2309061·Pk. of 200
HUMERIS 135
FDA UDI
FX SOLUTIONS·03701037318591·HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY PE/TA...
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857346697·Lordotic Rasp, Size 24x30x19 mm, 10°
ENDOFLIP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXCEL SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHITECT C4000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·September 1, 2011
ACCU-CHEK COMPACT PLUS (GT)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·November 6, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·May 29, 2024
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 23, 2024
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 12, 2024
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
FDA Enforcement
Class II
·Ongoing·TAS Medical Inc·March 12, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024