23 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIPOLAR PENCIL, MODEL 3901-002, 3900-002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDRAD® Veris™ 8600 Vital Signs Monitor
FDA UDI
BAYER MEDICAL CARE INC.·00616258009506·" Veris Water Trap 30/Box
(WATER TRAP, BOX OF 3...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540246530·Drill, WL 8mm, Dental Shaft
BACHER MEDIZINTECHNIK GMBH
FDA registration
BACHER MEDIZINTECHNIK GMBH·10 products·🇩🇪 Germany
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033164419·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033164402·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033164389·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033164396·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033164426·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033164372·
HARDYDISK CINOXACIN, 100 MCG
FDA 510(k)
FDA Class 2
·Microbiology
MEDTRADE PRODUCTS ALGINATE ISLAND
FDA 510(k)
FDA Unclassified
·Unknown
CELSITE ACCESS PORT
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014
G7 ACETABULAR LINER 10 DEG E1 LINER 36MM E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 23, 2024
STERIS RELIANCE SYNERGY
FDA Adverse Event
Malfunction
·STERIS CORPORATION·Product code FLE·February 27, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 1, 2011
DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·February 7, 2008
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022
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