FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
591 results
481–504 of 591
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Nov 25, 2002
ENDOTACK
K022853 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 90d
Cleared Nov 22, 2002
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022827 · MBI
Linvatec Corp.
Orthopedic · 88d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · MBI
Axya Medical, Inc.
Orthopedic · 88d
Cleared Jul 22, 2002
OPUS MAGNUM ANCHOR & INSTRUMENT SET
K020172 · MBI
Opus Medical, Inc.
Orthopedic · 186d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557 · MBI
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 80d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · MBI
Axya Medical, Inc.
Orthopedic · 73d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · MBI
Arthrex, Inc.
Orthopedic · 69d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · MBI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared Mar 26, 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · MBI
Dj Orthopedics, LLC
Orthopedic · 196d
Cleared Mar 21, 2001
DJ ORTHOPEDICS TIBIAL ANCHOR
K003960 · MBI
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared Mar 21, 2001
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003971 · MBI
Axya Medical, Inc.
Orthopedic · 89d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · MBI
Etzem Technologies, Inc.
Orthopedic · 88d
Cleared Feb 09, 2001
STERILE BUTTON PLATE
K010121 · MBI
Synthes (Usa)
Orthopedic · 24d
Cleared Nov 15, 2000
LITWIN CRUICATE ANCHOR
K002600 · MBI
Instrument Makar, Inc.
Orthopedic · 86d
Cleared Mar 15, 2000
SYNTHES BUTTON PLATE
K994364 · MBI
Synthes (Usa)
Orthopedic · 79d
Cleared Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · MBI
American Medical Systems, Inc.
Orthopedic · 30d
Cleared Jan 13, 2000
ACUMED SUTURE ANCHOR
K993657 · MBI
Acu Med, Inc.
Orthopedic · 77d
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261 · MBI
Mitek Products
Orthopedic · 64d
Cleared Oct 14, 1999
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992458 · MBI
Innovasive Devices, Inc.
Orthopedic · 83d
Cleared Oct 08, 1999
RC TACK
K992377 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d