18 results · 21ms · Sources: EU EUDAMED, 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