15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Richard Wolf GmbH·04055207014097·INSUFFLATION TUBE SET L 2.5M high-flow, reusable
LUMINESSE ZR BLANKS
FDA 510(k)
FDA Class 2
·Dental
ECG CABLES, TRUNK AND PATIENT LEAD WIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2013
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·July 5, 2011
D-FLEX TRIANGULAR RETRACTOR 80MM 5MM
FDA Adverse Event
Injury
·CAREFUSION·Product code GCJ·August 20, 2014
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021
TERUMO PROGREAT CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
FDA Enforcement
Class II
·Terminated·ASO, LLC·August 14, 2013
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024