19 results · 20ms · Sources: EU EUDAMED, US FDA

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WIENER LAB. CREATININA CINETICA AA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613067618·Stellbrink (Syvonectomy) Bone Rongeur, Fully Cu...

6.5 Cancellous Bone Screw, hex, St.Steel, L 65 mm

FDA UDI
mahe medical gmbh·EMAH00100120650·6.5 Cancellous Bone Screw, hex, St.Ste...

CorticaLINK

FDA UDI
LINKSPINE, INC.·00817329020356·5.0mm CoCr Rod: 65mm Curved

Integrity-SI Fusion System

FDA UDI
Lincotek Medical LLC·B57112521012065D0·12 x 65 mm Anodized SI Implant

12 x 65mm Anodized SI Implant

FDA UDI
Osteocentric Technologies, Inc.·00810097800038·12 x 65mm Anodized SI Implant

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659174283·6.5 Cancellous Bone Screw, hex, _x000D_...

STONETOME¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code LQR·October 26, 2017

PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR

FDA 510(k)
FDA Class 1 ·General Hospital

CRANIAL STEREOTACTIC EQUIPMENT

FDA 510(k)
FDA Class 2 ·Radiology

STONETOME¿

FDA Adverse Event
Malfunction ·Product code LQR·July 30, 2018

BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 28, 2021

ASR UNI FEMORAL IMPL SIZE 53

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 9, 2011

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FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·February 8, 2008

ENDOPATH ETS

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997

VAPR VUE WIRELESS FOOTSWITCH

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code GEI·December 26, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

FDA Enforcement
Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026