FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
106033–106056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · LFX
Abbott Laboratories
Microbiology · 658d
Cleared Dec 19, 1994
COAT-A-COUNT FREE ESTRIOL
K932989 · CGI
Diagnostic Products Corp.
Chemistry · 549d
Cleared Dec 19, 1994
IMMULITE RAPID TSH
K933212 · JLW
Diagnostic Products Corp.
Chemistry · 570d
Cleared Dec 19, 1994
ABBOTT CHAGAS ANTIBODY EIA
K933716 · MIU
Abbott Laboratories
Microbiology · 507d
Cleared Dec 19, 1994
RING ELECTRODE
K933805 · GXY
Cadwell Laboratories, Inc.
Neurology · 502d
Cleared Dec 19, 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · JLW
Bio-Rad
Chemistry · 405d
Cleared Dec 19, 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · JLW
Diagnostic Products Corp.
Chemistry · 347d
Cleared Dec 19, 1994
OREX
K940716 · EFQ
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 19, 1994
OREX
K940764 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 19, 1994
ISOLYSER
K940765 · EFQ
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 19, 1994
OREX (18X18 X-RAY DETECTABLE)
K940766 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 19, 1994
OREX (12X12 X-RAY DETECTABLE)
K940767 · GDY
Thantex Specialties, Inc.
General & Plastic Surgery · 304d
Cleared Dec 19, 1994
IMMULITE ALATOP ALLERGY SCREEN
K941564 · DHB
Diagnostic Products Corp.
Immunology · 262d
Cleared Dec 19, 1994
MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5
K941595 · FRN
Microject, Inc.
General Hospital · 262d
Cleared Dec 19, 1994
TOTAL TOE SYSTEM II
K941650 · LZJ
Biomet, Inc.
Orthopedic · 258d
Cleared Dec 19, 1994
ENDURANCE R3000
K942384 · CAF
Essential Medical Supply, Inc.
Anesthesiology · 214d
Cleared Dec 19, 1994
ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE
K942935 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 180d
Cleared Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
K943317 · LKT
Diagnostic Products Corp.
Microbiology · 161d
Cleared Dec 19, 1994
THE PROMPT GUIDWIRE
K943522 · DQX
Cordis Corp.
Cardiovascular · 154d
Cleared Dec 19, 1994
ANTERIOR CERVIAL PLATING SYSTEM
K943523 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Dec 19, 1994
RESTORATION ACETABULAR CUP
K943549 · JDI
Osteonics Corp.
Orthopedic · 151d
Cleared Dec 19, 1994
STERMED NON-CHLORINATED POWDER FREE GLOVES
K943839 · LYY
Steriltx (Usa), Inc.
General Hospital · 136d
Cleared Dec 19, 1994
IMMULITE PROGESTERONE
K944211 · JLS
Diagnostic Products Corp.
Chemistry · 112d
Cleared Dec 19, 1994
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · JTN
Difco Laboratories, Inc.
Microbiology · 111d