21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHO-WRAP BIORESORBABLE SHEET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Channel Drain
FDA UDI
C. R. Bard, Inc.·00801741049729·Channel Drain, 19 Fr. Round Full Fluted
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100744·K7-2190-39F
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100751·K7-2190-47F
19 FRENCH ROUND FLUTED JP DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD, INC.·Product code GBX·November 7, 2023
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AOS MODULAR FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2022
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 21, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 28, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 15, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 19, 2025
CHANNEL DRAIN
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code GBX·August 13, 2025
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
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
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026