18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Oclet TDS 1000
FDA 510(k)
FDA Unclassified
·Unknown
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·February 14, 2022
BD SMARTSITE¿ VENTED VIAL ADAPTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·July 29, 2022
TMJ IMPLANT FOSSA
FDA Adverse Event
Injury
·TMJ IMPLANTS, INC.·Product code LZD·October 24, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·July 8, 2013
11MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code JDS·September 2, 2020
BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·April 18, 2022
BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·July 29, 2022
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·April 6, 2017
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
Model Number L211 PROPONENT 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