21 results · 21ms · Sources: EU EUDAMED, US FDA

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RAICHEM PHOSPORUS REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964021143·Endo Carry-On Procedure Kit

Trinity Biotech

FDA UDI
MARDX DIAGNOSTICS, INC.·05391516748889·Trypanosoma cruzi 12 well slide, 8 each pack

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193105505·HA PEEK EVOS Straight, ,12mmx9mmx 22mm , FLAT ...

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF20030120·1.5mm Cortex Screw, 1.5 Hex, Self-Tapping, 12mm

XIPHOS ZFUZE

FDA UDI
Difusion Technologies, Inc.·00853896008335·TLIF Spacer 30mm Long x 12mm Height

VARELISA SM ANTIBODIES

FDA 510(k)
FDA Class 2 ·Immunology

IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AVEIR¿ DELIVERY CATHETER

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·October 20, 2025

VERCISE? CARTESIA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·October 27, 2025

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 13, 2013

PERMANENT CAUTERY SPATULA INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·February 28, 2011

GORE-TEX SOFT TISSUE PATCH

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES, INC.·Product code FTL·February 25, 2008

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023

BD BACTEC¿ MGIT¿ 960 SIRE KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

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 Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022