11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496002468·NAOMI 140, SIZE M, FUMO, GRADUATED COMPRESSION ...
RANDOX COMPLEMENT C4
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS CA 15-3 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
INFINION? PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 22, 2026
ASR UNI FEMORAL IMPL SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013
TRIDENT PSL HA CLUSTER 54 MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·February 16, 2011
FREESTYLE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC. USA·Product code LFR·February 21, 2008
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024