FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91969–91992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1997
DYNA T-2000 PHYSICAL THERAPY SYSTEM
K955808 · IMB
Thermia, Inc.
Physical Medicine · 682d
Cleared Nov 03, 1997
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT...
K964926 · ILJ
Joerns Healthcare, Inc.
Physical Medicine · 329d
Cleared Nov 03, 1997
THEROX INFUSION GUIDEWIRES
K971719 · DQX
Therox, Inc.
Cardiovascular · 178d
Cleared Nov 03, 1997
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730 · KWQ
Depuy, Inc.
Orthopedic · 178d
Cleared Nov 03, 1997
PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES
K971912 · GEX
Xintec Corporation
General & Plastic Surgery · 206d
Cleared Nov 03, 1997
ERCO-VAC
K972537 · LKY
Ercons, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893 · LZO
Howmedica Corp.
Orthopedic · 90d
Cleared Nov 03, 1997
KERBOULL CROSS
K972928 · JDI
Howmedica, Inc.
Orthopedic · 87d
Cleared Nov 03, 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE...
K972944 · DQX
Medtronics Interventional Vascular
Cardiovascular · 84d
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