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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91465–91488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1997
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
K972994 · JXG
Integra Neurocare, LLC
Neurology · 83d
Cleared Nov 03, 1997
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
K973023 · ILO
Hollister, Inc.
Physical Medicine · 81d
Cleared Nov 03, 1997
STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE...
K973031 · MRI
R. Thomas Grotz, M.D., Inc.
Physical Medicine · 81d
Cleared Nov 03, 1997
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
K973060 · KWQ
Depuy, Inc.
Orthopedic · 77d
Cleared Nov 03, 1997
APR POROUS HA HIP SYSTEM
K973124 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 75d
Cleared Nov 03, 1997
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
K973281 · MAI
United States Surgical, A Division of...
Orthopedic · 62d
Cleared Nov 03, 1997
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION...
K973378 · CAC
Fresenius USA, Inc.
Anesthesiology · 56d
Cleared Nov 03, 1997
QUICK-CARE BIOPSY NEEDLE
K973565 · KNW
Cook, Inc.
Gastroenterology & Urology · 45d
Cleared Nov 03, 1997
STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE...
K973627 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 40d
Cleared Oct 31, 1997
GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS
K963368 · DXZ
Glycar, Inc.
Cardiovascular · 430d
Cleared Oct 31, 1997
GLYCAR PERICARDIAL PATCH
K963967 · DXZ
Glycar, Inc.
Cardiovascular · 394d
Cleared Oct 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964098 · LTK
Bayer Corp.
Immunology · 385d
Cleared Oct 31, 1997
RETRIEVER II
K964210 · DQO
Target Therapeutics
Cardiovascular · 374d
Cleared Oct 31, 1997
TRUQUANT BR RIA
K965141 · MOI
Biomira USA, Inc.
Immunology · 312d
Cleared Oct 31, 1997
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
K970482 · KPL
Srs Intl.
Gastroenterology & Urology · 263d
Cleared Oct 31, 1997
MERCURY MEDICAL REUSABLE CPR BAG
K970756 · BTM
Mercury Medical
Anesthesiology · 242d
Cleared Oct 31, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
K971375 · EOB
Wilson Greatbatch Technologies, Inc.
Ear, Nose, Throat · 200d
Cleared Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · LTJ
Diagnostic Products Corp.
Immunology · 151d
Cleared Oct 31, 1997
CURVTEK TSR SYSTEM
K972860 · HSZ
Biolectron, Inc.
Orthopedic · 88d
Cleared Oct 31, 1997
AMPLAID 171S
K972862 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 88d
Cleared Oct 31, 1997
APOLLO
K972882 · KGI
Norland Corp.
Radiology · 87d
Cleared Oct 31, 1997
DUET GLUCOSE CONTROL MONITORING SYSTEM
K973140 · CGA
Lxn Corp.
Chemistry · 71d
Cleared Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · GIZ
Sigma Diagnostics, Inc.
Hematology · 59d
Cleared Oct 31, 1997
ACTIVE INTACT PTH
K973514 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 44d