10,000 results
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176ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JTB 700 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
IMPLANTABLE PACEMAKER PULSE-GENERATOR
FDA Adverse Event
Malfunction
·BIOTRONIK·Product code DXY·August 12, 2023
Device, Media Dispensing/Stacking
FDA classification
FDA Class 1
·Device, Media Dispensing/Stacking
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
JSB DENTAL, INC.
FDA registration
JSB DENTAL, INC.·2 products·🇺🇸 United States
JEB TECHNOLOGIES LIMITED
FDA registration
JEB TECHNOLOGIES LIMITED·3 products·🇬🇧 United Kingdom
PORTA
FDA UDI
JOB CORPORATION·04582373840071·Mobile X-ray system
BTB Korea Co.,Ltd
FDA registration
BTB Korea Co.,Ltd·4 products·🇰🇷 South Korea
P300-1T-B
FDA UDI
NAKANISHI INC.·04589551354481·
QuickSteer Introducer
FDA UDI
Tjb Medical, Inc.·00860009688407·Articulating Introducer with detachable handle,...
NORDENT MANUFACTURING INC
FDA UDI
NORDENT MANUFACTURING INC·00840018636330·COM PLACM INSDE #20 TIN DL-R H
NORDENT MANUFACTURING INC
FDA UDI
NORDENT MANUFACTURING INC·00840018636354·COMPOSITE INST. #20TA, 2TB DL
NORDENT MANUFACTURING INC
FDA UDI
NORDENT MANUFACTURING INC·00840018635654·COMPOSITE INST. #20TA, 2TB
FUJIFILM
FDA UDI
FUJIFILM CORPORATION·04547410389005·This product is intended to be used in combinat...
THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·AOMORI OLYMPUS CO., LTD.·Product code GEI·February 5, 2026
BTB LACTOSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Parcus GFS BTB
FDA 510(k)
FDA Class 2
·Orthopedic
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823103772·
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823103758·
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823103765·