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
174409–174432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1977
LYMPHOCYTE TYPING, POSITIVE CONTROL
K761009 · LGO
Hyland Therapeutic Div., Travenol...
Hematology · 155d
Cleared Apr 06, 1977
MINICON
K770398 · JJH
Amicon, Inc.
Immunology · 35d
Cleared Apr 06, 1977
EXERCISER, EXTENSOR WAND
K770436 · ION
Maddak, Inc.
Physical Medicine · 30d
Cleared Apr 06, 1977
IN VITRO T-3 UPTAKE TEST
K770480 · KHQ
Clinical Assays, Inc.
Immunology · 26d
Cleared Apr 06, 1977
RIA-DAC TM HTSH KIH
K770604 · JLW
Mallinckrodt Critical Care
Immunology · 6d
Cleared Apr 06, 1977
STOCKINETTE, SURGICAL
K770621 · KKX
The Torrent Corp.
General Hospital · 5d
Cleared Apr 05, 1977
NDNA IMMUNOPATH FLUORO-KIT
K770057 · DHN
Clinical Sciences, Inc.
Immunology · 84d
Cleared Apr 05, 1977
CARDIAC CATHETERIZATION LAB MONITOR SYS
K770179 · DXG
General Electric Co.
Cardiovascular · 68d
Cleared Apr 05, 1977
T3 RIA (PEG) DIAGNOSTIC KIT
K770201 · CDP
Abbott Laboratories
Toxicology · 64d
Cleared Apr 05, 1977
STERILE SUCTION CATHETER W/CONTROL
K770233 · JOL
Chesire Laboratories
General Hospital · 57d
Cleared Apr 05, 1977
OVERDOSE KIT
K770238 · FMF
American Hospital Supply Corp.
Toxicology · 57d
Cleared Apr 05, 1977
MICROFILTRATION SET MF10
K770253 · CAK
Biotest-Serum-Institut
General Hospital · 55d
Cleared Apr 05, 1977
ANALYZER, 751 KINETIC/ENDPOINT
K770306 · JJQ
Sclavo, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
MICRO/PETTOR, SMI
K770307 · JQW
Lederle Laboratories
Chemistry · 58d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, NORMAL
K770310 · JJY
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, ABNORMAL
K770312 · JJY
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT LDH-L, ENZYME
K770313 · CFJ
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
BUN, ENZYMATIC
K770315 · CDQ
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT GOT, ENZYME
K770318 · CIT
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT CPK, ENZYME
K770319 · CGS
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
PHALDEBAS DIGOXIN RIA
K770322 · LCS
Pharmacia, Inc.
Toxicology · 47d
Cleared Apr 05, 1977
WOMB PREP KIT
K770329 · GEN
American Hospital Supply Corp.
General & Plastic Surgery · 47d
Cleared Apr 05, 1977
METER, IV PH, MODEL ZEROMATIC
K770351 · JQY
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Apr 05, 1977
TRAY, BLOOD GAS, CAT. NO. 4010
K770361 · FMF
Concord Laboratories, Inc.
General Hospital · 42d