29 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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ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ITL
FDA UDI
Preat Corporation·00842092104996·Square Type .050 Square Driver - Medium
Bio2 Technologies
FDA UDI
BIO2 TECHNOLOGIES, INC.·B01010000671·VITRIUM C
SMALL, 6 x 16
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014601632·Schure Slide, Anti-Static
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·September 29, 2023
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·November 22, 2023
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917022376·Personal Use Kit OC-Auto, for North Chicago, IL
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917027258·OC-Auto SENSOR io Personal Use Kit for VA North...
QB1 NMES System
FDA UDI
Motive Health, Inc.·00854816006417·QB1 Post-Op Brace, NMES System; 2X-LARGE, SHORT...
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555115000067·Cross Connector Driver - Hex
Matrix Holter System
FDA UDI
GLOBAL INSTRUMENTATION, LLC·90815187020382·M12A Office System Software
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555244000067·Ratcheting T-handle Torque Wrench, 80 in-lb
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
FDA 510(k)
FDA Class 2
·General Hospital
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·May 29, 2025
SMR REVERSE HUMERAL BODY
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·October 21, 2022
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 4, 2013
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 24, 2011
FREESTYLE FLASH
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·February 15, 2008
ACTIMPROM POC TEST 10/BOX
FDA Adverse Event
Malfunction
·COOPERSURGICAL INC.·Product code OAM·March 25, 2021