29 results · 20ms · Sources: EU EUDAMED, 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