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

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176,076 results
69049–69072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2004
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION...
K041188 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 26d
Cleared Jun 01, 2004
NIC36 AMPLIFIER
K041198 · GWL
Eb Neuro S.P.A.
Neurology · 25d
Cleared Jun 01, 2004
MEDI-PUMP ASPIRATOR, MODEL 1615
K041199 · BTA
Thomas Industries
General & Plastic Surgery · 25d
Cleared May 28, 2004
PH BUFFERING PLASTIC APPLICATOR TAMPON
K030474 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 471d
Cleared May 28, 2004
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
K032170 · CAF
Medical Industries America, Inc.
Anesthesiology · 317d
Cleared May 28, 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
K032522 · JWH
Exactech, Inc.
Orthopedic · 287d
Cleared May 28, 2004
KOLPEXIN SPHERE
K032644 · HHW
Adamed , Ltd.
Obstetrics & Gynecology · 275d
Cleared May 28, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
K033458 · LON
Becton, Dickinson & CO
Microbiology · 211d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K033971 · MBH
Howmedica Osteonics Corp.
Orthopedic · 158d
Cleared May 28, 2004
LITTLE GRAFTER SCREW
K040265 · HWC
Biocomposites, Ltd.
Orthopedic · 113d
Cleared May 28, 2004
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K040293 · LCO
Akers Laboratories, Inc.
Hematology · 112d
Cleared May 28, 2004
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044...
K040544 · LPH
Depuy, Inc.
Orthopedic · 87d
Cleared May 28, 2004
MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
K040552 · DYB
Cryocor, Inc.
Cardiovascular · 87d
Cleared May 28, 2004
OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004
K040664 · ILY
Omnilight, Inc.
Physical Medicine · 79d
Cleared May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · DIF
Microgenics Corp.
Toxicology · 64d
Cleared May 28, 2004
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
K040891 · DZE
KLS-Martin L.P.
Dental · 53d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
K040964 · JWH
Howmedica Osteonics Corp.
Orthopedic · 44d
Cleared May 28, 2004
PROFEMUR TAPERED HIP STEM
K041114 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared May 28, 2004
GII QUICKANCHOR PLUS
K041115 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 29d
Cleared May 28, 2004
SUPER QUICKANCHOR PLUS
K041116 · JDR
Depuy Mitek
Orthopedic · 29d
Cleared May 28, 2004
PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730
K041117 · JDR
Depuy Mitek
Orthopedic · 29d
Cleared May 28, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041118 · MNI
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared May 28, 2004
MODIFICATION TO BONE GRAFT WASHER
K041217 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared May 28, 2004
PROCERA BRIDGE ZIRCONIA
K041283 · ELL
Nobel Biocare AB
Dental · 15d