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