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

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REGUTHERM 952 THERMOGRAPHIC SYSTEM

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964022041·The ENDO CARRY-ON Procedure Kit contains all of...

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00531301·

Imola-Silverstone

FDA UDI
Altus Spine, LLC·00843210133492·Main Blade, 130mm Long

FacetFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361019961·Facet Screw Assy, SOTW, 5.0 x 30mm

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07310K0131300·Rod Inserter, Articulating, MIS

3D MANUAL COARSE MANIPULATOR MN-188NE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HARDYDISK, NALIDIXIC ACID, 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

BLOOD GROUPING REAGENT ANTI-A (ABO1)

FDA Adverse Event
Malfunction ·BIO-RAD MED DIAGNOSTICS GMBH·Product code KSF·January 17, 2011

BLOOD GROUPING REAGENT ANTI-A (ABO1)

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·January 24, 2011

VIDAS® RUB IGG II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LFX·September 10, 2019

BLOOD GROUPING REAGENT ANTI-A (ABO1)

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·December 16, 2010

ENDO RETRACT II 10MM INSTRUMENT

FDA Adverse Event
Malfunction ·COVIDIEN FORMERLY USSC PUERTO RICO, INC.·Product code GAD·June 26, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·February 28, 2011

VITROS XT 7600 INTEGRATED SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·February 5, 2026

VIDAS® BRAHAMS PROCALCITONIN

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code PRI·September 16, 2019

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·December 10, 2014

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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