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: Cleared only ×
176,076 results
66697–66720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2005
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS
K043248 · HTN
Arthrex, Inc.
Orthopedic · 85d
Cleared Feb 16, 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · MQV
Depuy Spine, Inc.
Orthopedic · 77d
Cleared Feb 16, 2005
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
K043374 · MBH
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Feb 16, 2005
VASCON POLARIS GUIDING CATHETER
K043387 · DQY
Vascon, LLC
Cardiovascular · 69d
Cleared Feb 16, 2005
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
K043421 · MQV
Regeneration Technologies, Inc.
Orthopedic · 65d
Cleared Feb 16, 2005
GAMMA3 NAIL SYSTEM
K043431 · HSB
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Feb 16, 2005
SPACELINE EMCIA, MODEL CU580
K043496 · EIA
J. Morita USA, Inc.
Dental · 61d
Cleared Feb 16, 2005
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
K043498 · EFB
J. Morita USA, Inc.
Dental · 61d
Cleared Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · FGE
Abbott Laboratories
Gastroenterology & Urology · 29d
Cleared Feb 16, 2005
APEX MEDICAL MININEB & MINIPLUS
K050104 · CAF
Apex Medical Corp.
Anesthesiology · 29d
Cleared Feb 16, 2005
EBI TROCHANTERIC NAIL SYSTEM
K050118 · HSB
Ebi, L.P.
Orthopedic · 29d
Cleared Feb 16, 2005
TECHTONIX SYSTEM
K050189 · KWP
Stryker Spine
Orthopedic · 20d
Cleared Feb 16, 2005
TURBO TEMP TRIO
K050230 · FLL
Cardinal Health, Alaris Products
General Hospital · 15d
Cleared Feb 15, 2005
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
K040958 · JJE
Tokyo Boeki Medical System , Ltd.
Chemistry · 308d
Cleared Feb 15, 2005
8NONE
K041839 · LGZ
Medical Solutions, Inc.
General Hospital · 222d
Cleared Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735 · CFN
Dade Behring, Inc.
Immunology · 137d
Cleared Feb 15, 2005
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884 · MXZ
Dakocytomation California, Inc.
Pathology · 119d
Cleared Feb 15, 2005
USCOM 1A
K043139 · IYN
Uscom, Ltd.
Radiology · 95d
Cleared Feb 15, 2005
ACHIEVA FAMILY
K043147 · LNH
Philips Medical Systems North America...
Radiology · 92d
Cleared Feb 15, 2005
RANDOX URINE CONTROLS
K043266 · JJW
Randox Laboratories, Ltd.
Chemistry · 81d
Cleared Feb 15, 2005
SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
K043268 · CEI
Randox Laboratories, Ltd.
Chemistry · 81d
Cleared Feb 15, 2005
PLANET 50 MONITORING SYSTEM
K043370 · MWI
Larsen & Toubro Limited
Cardiovascular · 69d
Cleared Feb 15, 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 63d
Cleared Feb 15, 2005
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK...
K043476 · NBC
Dade Behring, Inc.
Chemistry · 61d