18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dental Glass Ceramics
FDA 510(k)
FDA Class 2
·Dental
Ricca Chemical Company®
FDA UDI
Ricca Chemical Company, LLC·00192024025722·Copper Sulfate, 1.053 Specific Gravity at 25°C ...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2330165·Rotary diamond instrument
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2330162·Rotary diamond instrument
FG Dental Burs
FDA UDI
BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119312009·
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
FDA 510(k)
FDA Class 2
·Neurology
VENT-OS SINUS DILATION SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ATRAUM
FDA Adverse Event
Malfunction
·AXIOM MEDICAL INC.·Product code KDQ·November 11, 2008
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 20, 2011
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 18, 2013
PIRANHA
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code JCX·May 21, 2020
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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