21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LENSX LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704300808·Green Non-Latex Robertazzi Nasopharyngeal Airwa...
Forestanit®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21231201·Forestanit wire round hard clinic coil 1,20 mm
SCOTT'S SELECT K-FILES 6/pk 31mm # 20
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811231201·ENDODONTIC K-FILES (6/pack) Length: 31mm, Size:...
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 19, 2021
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·January 15, 2021
CORIN BIOLOX DELTA FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
OXYCON MOBILE
FDA 510(k)
FDA Class 2
·Anesthesiology
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 9, 2014
QUICK CHECK ONE
FDA Adverse Event
DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·February 7, 1997
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 20, 2024
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·July 3, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
GYNECARE MORCELLEX UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code HET·October 2, 2015
CAREEVENT
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MSX·June 6, 2024
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·June 14, 2023
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 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