Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: MBI ×
607 results
553–576 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Dec 01, 1997
ACL CLIP-IN
K973323 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · MBI
Mitek Products
Orthopedic · 89d
Cleared Oct 28, 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · MBI
Howmedica Corp.
Orthopedic · 420d
Cleared Oct 09, 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622 · MBI
Influence, Inc.
Orthopedic · 87d
Cleared Oct 09, 1997
MULTITAK SS SUTURE SYSTEM
K973015 · MBI
Bonutti Research
Orthopedic · 57d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Aug 26, 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · MBI
Innovasive Devices, Inc.
Orthopedic · 62d
Cleared Aug 07, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971922 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723 · MBI
Arthrex, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
K971791 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
K971802 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · MBI
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Jun 27, 1997
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 81d
Cleared Jun 25, 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · MBI
Boston Scientific Corp
Orthopedic · 89d
Cleared Jun 25, 1997
MULTITAK SS SUTURE SYSTEM
K971144 · MBI
Bonutti Research
Orthopedic · 89d
Cleared Jun 20, 1997
PRELOADED SOFT TISSUE ANCHOR
K963932 · MBI
Linvatec Corp.
Orthopedic · 262d
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