FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
601 results
553–576 of 601
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
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