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
153505–153528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1984
FILTRARE TM ALLVENT TM
K834376 · FPB
Alltek, Inc.
General Hospital · 149d
Cleared May 11, 1984
YD STRIP GLUCOSE U19
K834385 · JIL
Yd Pharmaceutical Corp.
Chemistry · 149d
Cleared May 11, 1984
PRESTON CAMPYLOBACTER SELECTIVE SUPP
K840330 · JSK
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · JSK
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
CAMPYLOBACTER AGAR BASE
K840332 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · JSK
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
OBSTETRICAL ULTRASOUND COMPUTER
K840623 · HEM
R & S Systems
Obstetrics & Gynecology · 87d
Cleared May 11, 1984
OPAQUE COATING & SURFACE STAIN
K840751 · EBD
Dentsply Intl.
Dental · 78d
Cleared May 11, 1984
ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
K840867 · DEI
Intl. Diagnostic Technology
Immunology · 74d
Cleared May 11, 1984
TDX ACETAMINOPHEN
K840941 · LDP
Abbott Laboratories
Toxicology · 67d
Cleared May 11, 1984
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · HRS
Synthes (Usa)
Orthopedic · 67d
Cleared May 11, 1984
SURGICAL CURETTE, VARIOUS
K841004 · HCY
Premier Dental Products Co.
Obstetrics & Gynecology · 63d
Cleared May 11, 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118 · CFT
Abbott Laboratories
Chemistry · 57d
Cleared May 11, 1984
HY-BOND ZINC OXIDE EUGENOL TEMP.
K841196 · EMA
Shofu Dental Corp.
Dental · 51d
Cleared May 11, 1984
ULTRACLONE ECL-01-800 CELL LINE
K841337 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-600 CELL LINE
K841338 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRA CLONE ECL-01-700 CELL LINE
K841339 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-900 CELL LINE
K841340 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-1000 CELL LINE
K841341 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-400 CELL LINE
K841342 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-100 CELL LINE
K841343 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-300 CELL LINE
K841344 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-500 CELL LINE
K841345 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-200 CELL LINE
K841346 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 39d