15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K152468
FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 18, 2023
ZOLL PROPAQ MD
FDA 510(k)
FDA Class 2
·Cardiovascular
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BINAXNOW COVID-19 TEST
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 6, 2022
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 22, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 15, 2011
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
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