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: OLO ×
445 results
409–432 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Nov 30, 2012
NAVIOPFS
K121936 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 151d
Cleared Nov 30, 2012
SMARTTOOLS KNEE SYSTEM
K122326 · OLO
Zimmer
Orthopedic · 121d
Cleared Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · OLO
Brainlab AG
Orthopedic · 129d
Cleared Sep 20, 2012
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
K120867 · OLO
Medos International SARL
Orthopedic · 182d
Cleared Jun 06, 2012
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
K121064 · OLO
Mako Surgical Corporation
Orthopedic · 61d
Cleared Mar 01, 2012
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
K112507 · OLO
Mako Surgical Corporation
Orthopedic · 184d
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