18 results
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21ms
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Sources: EU EUDAMED, US FDA
YARMO NASAL CARTILAGE SOFTENER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Preat
FDA UDI
Preat Corporation·00842092138557·Sphero Block Abutment Astra EV 3.0 x 5mm (2.5mm...
ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (D)
FDA UDI
STERNGOLD DENTAL LLC·00841549105654·Implant retained overdentures are an establishe...
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
FDA 510(k)
FDA Class 2
·Microbiology
Wilson-Cook Achalasia Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROTATABLE SNARE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·May 15, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
MD - DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·August 24, 2010
APPLICATION INSTRUMENT FOR SNAL ZIPFIX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDQ·March 23, 2021
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code PID·June 17, 2021
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JDQ·July 21, 2016
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code JDQ·June 13, 2016
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PID·October 6, 2020
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDQ·August 27, 2018
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDQ·November 5, 2019
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDQ·November 15, 2019
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDQ·October 22, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022