11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAMONDS BURS-COMPOSIT FINISHING
FDA 510(k)
FDA Class 1
·Dental
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 7, 2025
DELTA CER FEM HD 32/+6MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·September 11, 2019
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
MESH- COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 4, 2010
UNKNOWN DEPUY SZ 4 12.5MM TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 10, 2012
EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 7, 2022
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022