12 results
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18ms
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Sources: EU EUDAMED, US FDA
GRAVIDAPHONE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Integra® Total Foot System
FDA UDI
Ascension Orthopedics, Inc.·10381780119357·The Integra Total Foot System Universal Rearfoo...
Total Foot System 2
FDA UDI
Smith & Nephew, Inc.·00885556838099·REAR FOOT UNIVERSAL PLATE. 24MM
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18020242·ET 20mL Luer Lock Barrel Only (TB)
Two Striper
FDA UDI
ABRASIVE TECHNOLOGY, INC.·B868C8020241·Dental Root Canal Post
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515207929·Heath Chal Curette, #3, 3mm
RPM RESPIRATORY GATING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
FDA 510(k)
FDA Class 2
·Microbiology
ABL800 FLEX
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·February 12, 2014
M2A-MAGNUM MODULAR HEAD SZ 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021