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
553–576 of 591
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 30, 1997
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970423 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Apr 23, 1997
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
K970292 · MBI
Influence, Inc.
Orthopedic · 89d
Cleared Apr 16, 1997
INNOVASIVE 8MM LIGAMENT FASTENER
K970316 · MBI
Innovasive Devices, Inc.
Orthopedic · 82d
Cleared Mar 25, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
K970089 · MBI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Feb 24, 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K964945 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Feb 18, 1997
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR...
K965111 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 12, 1997
ANSPACH SUTURE ANCHOR
K965069 · MBI
The Anspach Effort, Inc.
Orthopedic · 61d
Cleared Feb 07, 1997
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE...
K964927 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 06, 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 03, 1997
MULTITAK SS SUTURE SYSTEM
K964532 · MBI
Bonutti Research
Orthopedic · 83d
Cleared Jan 10, 1997
MULTITAK SS SUTURE SYSTEM
K964324 · MBI
Bonutti Research
Orthopedic · 72d
Cleared Nov 25, 1996
ANSPACH SUTURE ANCHOR (MODIFIED)
K963686 · MBI
The Anspach Effort, Inc.
Orthopedic · 74d
Cleared Nov 13, 1996
LM BONE ANCHOR
K963288 · MBI
Li Medical Technologies, Inc.
Orthopedic · 84d
Cleared Nov 12, 1996
LM BONE ANCHOR (ORTHOPEDICS)
K963812 · MBI
Li Medical Technologies, Inc.
Orthopedic · 64d
Cleared Nov 06, 1996
MITEK MICRO ANCHOR
K962511 · MBI
Mitek Products
Orthopedic · 132d
Cleared Nov 04, 1996
INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
K963402 · MBI
Innovasive Devices, Inc.
Orthopedic · 67d
Cleared Oct 03, 1996
MITEK THREADED ANCHOR (MODIFICATION)
K961094 · MBI
Mitek Products
Orthopedic · 203d
Cleared Oct 02, 1996
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 48d
Cleared Oct 02, 1996
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 47d
Cleared Aug 27, 1996
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397 · MBI
Zimmer, Inc.
Orthopedic · 67d
Cleared Jul 30, 1996
MLI SOFT TISSUE SCREW & WASHER SYSTEM
K962194 · MBI
Medicinelodge, Inc.
Orthopedic · 53d
Cleared Apr 30, 1996
LM ANCHOR OR OTHER PROPRIETARY NAME
K960825 · MBI
Li Medical Technologies, Inc.
Orthopedic · 61d
Cleared Apr 23, 1996
QUESTLOCK ACL FIXATOR
K954683 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 195d
Cleared Apr 18, 1996
LM BONE ANCHOR
K960439 · MBI
Li Medical Technologies, Inc.
Orthopedic · 78d