Smith & Nephew Endoscopy, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSFebruary 3, 2011
K102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSDecember 13, 2010
K093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORDecember 17, 2009
K083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWJanuary 30, 2009
K083226SMITH & NEPHEW PEEK INTERFERENCE SCREWJanuary 30, 2009
K082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICEOctober 21, 2008
K050580SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMSApril 20, 2005
K992396BIORCI SCREWJanuary 12, 2000
K991500SMITH & NEPHEW SUTURE LOKJuly 14, 1999
K972599ACUFEX SCREW CANNULASeptember 19, 1997
K971939SMITH & NEPHEW SUTURE COLLETAugust 6, 1997
K970949SMITH & NEPHEW MIS INSTRUMENTSApril 23, 1997
K970416ACUFEX DOUBLE ARMED SUTURE NEEDLEApril 21, 1997
K964935SUTURE LOCKFebruary 25, 1997
K964215ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEMDecember 20, 1996
K963901ELECTROSURGICAL PROBENovember 4, 1996
K962789SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEMAugust 14, 1996
K961649ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHERJuly 16, 1996