Nobelpharma USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
64
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984162BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USEJune 28, 1999
K962403NOBLEPHARMA WIDE ACCESSORIESSeptember 6, 1996
K955713NOBELPHARMA BONE ANCHORED HEARING AIDAugust 9, 1996
K962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTUREJuly 22, 1996
K96173617 ANGULATED ABUTMENTJuly 18, 1996
K961737CERA ONE ABUTMENT SYSTEMJuly 10, 1996
K961728MIRUSCONE ABUTMENT SYSTEMJuly 10, 1996
K960639ABUTMENT SELECTION KITMay 14, 1996
K955697ABUTMENT RETRIEVAL KITJanuary 30, 1996
K955372BALL ATTACHMENT SYSTEMJanuary 23, 1996
K953435BRANEMARK RADIOGRAPHIC DEPTH GUAGEOctober 3, 1995
K953774BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAYSeptember 27, 1995
K953775BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)September 21, 1995
K952685BRANEMARK SYSTEM DRILLS AND COUNTERSINKSSeptember 18, 1995
K952886BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEMSeptember 18, 1995
K952676BRANEMARK SYSTEM BALL ATTACHMENT SYSTEMAugust 11, 1995
K933148SURGICAL DRAPE KITJune 26, 1995
K9524483.3MM ACCESSORIESJune 20, 1995
K945398BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTUREApril 13, 1995
K944683BRANEMARK SYSTEM 3.3MM FIXTUREMarch 8, 1995