18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAAS QVA 3D, CAAS QCA 3D
FDA 510(k)
FDA Class 2
·Radiology
Bur PM2-70 50K Steel Ø1.0
FDA UDI
Bien-Air Surgery SA·07630055502650·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780178781·Integra® Jarit® Flat Tip Scissors, 9-1/4", Curved
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958001536·600 Micron Disposable ND YAG Nozzle Tip Laser L...
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047068·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE BLADE
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319736470·Knapp Iris Scissors 4" (10cm), straight, sharp-...
BREG
FDA UDI
BREG, INC.·00672736026700·
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
DRX 2000
FDA 510(k)
FDA Class 2
·Physical Medicine
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 8, 2023
BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 26, 2020
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·July 7, 2022
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code MCX·May 8, 2013
ABBOTT M2000SP
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
FDA Enforcement
Class II
·Terminated·Ideal Implant Incorporated·August 14, 2019
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020