19 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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
*
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