22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TETHER ACFS
FDA 510(k)
FDA Class 2
·Orthopedic
VIvid NuFil Syringe B-2
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0104660·
MEDRAD® Veris™ 8600 Vital Signs Monitor
FDA UDI
BAYER MEDICAL CARE INC.·00616258009568·"BP CUFF, ADULT, 25-35cm, VERIS
(NIBP Cuff (25-...
MedGyn Video Colposcope
FDA UDI
MEDGYN PRODUCTS, INC.·M803010466·Video Colposcope
Clearo Patient Circuit Americas
FDA UDI
Breas Medical AB·07321820104666·Clearo Patient Circuit Americas
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033152331·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033152317·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033152324·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033152300·
VOCOM SILICONE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
INSET I
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 11, 2025
INSET I
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 8, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 31, 2020
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
TOTAL ASR FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·March 19, 2013
INTELEPACS
FDA Adverse Event
Malfunction
·INTELERAD MEDICAL SYSTEMS·Product code LLZ·March 2, 2011
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 14, 2010
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019