22 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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POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994325846·CONNECTOR 7022220 LAT CONN SS 4.5 22MM
Safco Gates Glidden Drills
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310222203·Safco Gates Glidden drills, #03, 32mm, 6/box
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113553·PS-C Insert, Size 2 x 20mm
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981173661·Closed, Axial Rod, Long, 220mm
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ NORTH AMERICA, INC·Product code LNM·October 17, 2013
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
TAO EMBRYO TRANSFER CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NAUTILUS REAMER/DRILL GLOVE PROTECTOR
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·April 29, 2024
NAUTILUS REAMER/DRILL GLOVE PROTECTOR
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·April 29, 2024
COAPTITE
FDA Adverse Event
Other
·MERZ AESTHETICS, INC·Product code LNM·October 17, 2012
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ AESTHETICS, INC·Product code LNM·October 17, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 19, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011
KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code KNT·March 26, 2008
STOCKERT CORONARY PERFUSION CANNULAE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 18, 2025
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018