FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: OLO ×
439 results
409–432 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Dec 05, 2011
BENDINI(TM) SPINAL ROD BENDING SYSTEM
K111811 · OLO
Nuvasive, Inc.
Orthopedic · 161d
Cleared Nov 14, 2011
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
K111843 · OLO
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 138d
Cleared Oct 18, 2011
DASH HIP
K110021 · OLO
Brainlab AG
Orthopedic · 288d
Cleared Sep 29, 2011
X12 STERILE REFLECTIVE MARKER SPHERE
K111443 · OLO
Pinsco Inc. Dba B & L Engineering
Orthopedic · 128d
Cleared Aug 05, 2011
BRAINLAB TRAUMA
K110204 · OLO
Brainlab AG
Orthopedic · 193d
Cleared May 17, 2011
DASH KNEE
K102251 · OLO
Brainlab AG
Orthopedic · 281d
Cleared Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · OLO
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Apr 04, 2011
BRAINLAB KNEE
K102990 · OLO
Brainlab AG
Orthopedic · 178d
Cleared Apr 04, 2011
KNEEALIGN SYSTEM
K103829 · OLO
Orthalign, Inc.
Orthopedic · 95d
Cleared Mar 24, 2011
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
K110054 · OLO
Zimmer Cas
Orthopedic · 76d
Cleared Mar 07, 2011
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
K103400 · OLO
Stryker Corporation
Radiology · 108d
Cleared Nov 04, 2010
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
K102967 · OLO
Smith & Newphew, Inc.
Orthopedic · 30d
Cleared Oct 21, 2010
EXACTECH GPS
K100742 · OLO
Blue Ortho
Orthopedic · 219d
Cleared Aug 04, 2010
ORTHOMAP 3D 1.1 MODULE
K093206 · OLO
Stryker Corp.
Orthopedic · 295d
Cleared Jun 11, 2010
BRAINLAB KNEE ARTHROSCOPY
K093118 · OLO
Brainlab AG
Orthopedic · 252d
Cleared Apr 05, 2010
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR,...
K100599 · OLO
Orthosoft, Inc.
Orthopedic · 33d
Cleared Mar 22, 2010
KNEEALIGN SYSTEM WITH REFERENCE SENSOR
K093998 · OLO
Orthalign, Inc.
Orthopedic · 84d
Cleared Feb 24, 2010
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
K093425 · OLO
Mako Surgical Corp.
Orthopedic · 113d
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Smith & Nephew, Inc.
Orthopedic · 40d
Cleared Jan 21, 2010
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
K090953 · OLO
Praxim Medivision, SA
Orthopedic · 293d
Cleared Sep 28, 2009
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · OLO
Mako Surgical Corp.
Orthopedic · 88d
Cleared Sep 25, 2009
KNEEALIGN SYSTEM
K091411 · OLO
Orthalign, Inc.
Orthopedic · 135d
Cleared Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · OLO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 23, 2009
ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
K090375 · OLO
Aesculap Implant System, Inc.
Orthopedic · 126d