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