69 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302730531015·Young Prophy Cup, Soft, Long, Gray Spiraled Tur...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844825·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE MEDIUM...
CarePoint Precision
FDA UDI
ALLISON MEDICAL, INC.·00786227053158·3ml Luer Lock Syringe w/ 20G x 1"
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
FDA Enforcement
Class II
·Terminated·Accuray Incorporated·June 12, 2019
P102 INL MECH, S102, 1', NO DP, CURBELL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828136334·P102 INL MECH, S102, 1', NO DP, CURBELL
Phonak Virto I70-10 NW O
FDA UDI
Sonova AG·07613389626308·
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 28, 2021
ABUT GOLD FRICTION-FIT 3. 5MM IMP
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·April 3, 2018
ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·August 31, 2022
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011
ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER
FDA Adverse Event
Malfunction
·HOLLISTER INC.·Product code CBH·May 19, 2008
ABUT GOLD FRICTION-FIT 4. 5MM IMP
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·July 14, 2021
ABUT GOLD FRICTION-FIT 3. 5MM IMP
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·April 3, 2018
ABUT GOLD FRICTION-FIT 3. 5MM IMP
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·April 2, 2018
ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2017
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·April 10, 2018