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
505–528 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Mar 05, 1999
MULTITAK SS BUTTONS
K990156 · MBI
Bonutti Research
Orthopedic · 45d
Cleared Mar 05, 1999
BONE ANCHOR SYSTEM III (BAS III)
K990295 · MBI
Boston Scientific Corp
Orthopedic · 35d
Cleared Feb 16, 1999
MICROTAC-BONE ANCHOR SYSTEM
K990160 · MBI
Influence, Inc.
Orthopedic · 28d
Cleared Feb 01, 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · MBI
Implex Corp.
Orthopedic · 179d
Cleared Feb 01, 1999
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K990095 · MBI
Influence, Inc.
Orthopedic · 20d
Cleared Jan 28, 1999
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K983560 · MBI
Innovasive Devices, Inc.
Orthopedic · 107d
Cleared Jan 21, 1999
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM
K984200 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 58d
Cleared Dec 18, 1998
STRYKER WEDGE SUTURE ANCHOR
K983557 · MBI
Stryker Endoscopy
Orthopedic · 66d