21 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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Halo One Thin-Walled Guiding Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000529·ProKit Aneroid Sphygmomanometer With Dual-Head ...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327466829·LE FORT I PLATE, 8MM ADVANCEMENT, RIGHT
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837067250·Custom Small Anatomical Spacer, 7degree, 8mm
REMESENSE FOR SENSITIVE TEETH
FDA 510(k)
FDA Class 2
·Dental
ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
PMT CORPORATION·00650551143116·INTERCONNECTION CABLE, 32 CONTACT (8X4), INLINE...
N/A
FDA UDI
PMT CORPORATION·00650551143130·INTERCONNECTION CABLE, 64 CONTACT (8X8), INLINE...
N/A
FDA UDI
PMT CORPORATION·00650551142911·INTERCONNECTION CABLE, 8 CONTACT (8X1), INLINE ...
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981038083·27x21mm Trial 8mm 12 deg. The Vu a-POD interve...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
N/A
FDA UDI
PMT CORPORATION·00650551143147·INTERCONNECTION CABLE, 64 CONTACT (8X8), INLINE...
N/A
FDA UDI
PMT CORPORATION·00650551143123·INTERCONNECTION CABLE, 32 CONTACT (8X4), INLINE...
N/A
FDA UDI
PMT CORPORATION·00650551143017·INTERCONNECTION CABLE, 8 CONTACT (8X1), INLINE ...
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2008
OPTI-FREE REPLENISH
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·August 11, 2011
STEPDRILL FOR LAG SCREW T2 RECON
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·July 9, 2013
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
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