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
151513–151536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1984
ULTRACLONE ECL-01-2100 CELL LINE
K843578 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Oct 31, 1984
ULTRACLONE ECL-01-1100
K843579 · KIR
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Oct 31, 1984
AUTO SUTURE POLY GIA SURGICAL STAPLER
K843603 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 72d
Cleared Oct 31, 1984
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
K843613 · GMS
Immuno-Products Industries
Immunology · 51d
Cleared Oct 31, 1984
AVI GUARDIAN MICRO 410 INFUSION PUMP
K843615 · FRN
Avi, Inc.
General Hospital · 47d
Cleared Oct 31, 1984
AVI GUARDIAN 400 INFUSION PUMP
K843616 · FRN
Avi, Inc.
General Hospital · 47d
Cleared Oct 31, 1984
SIGMA SUDAN BLACK REAGENT 380-1
K843684 · HZZ
Sigma Chemical Co.
Hematology · 43d
Cleared Oct 31, 1984
FLU VEN I.V. SET 0153-C PERMA-SET
K843692 · FPA
Venusa , Ltd.
General Hospital · 42d
Cleared Oct 31, 1984
JACOBS HIGH VACUUM SUCTION UNIT 05-2570
K843693 · BTA
J. Sklar Mfg. Co., Inc.
General & Plastic Surgery · 42d
Cleared Oct 31, 1984
MCGHAN TISSUE EXPANDER
K843704 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 40d
Cleared Oct 31, 1984
RAICHEM X-HBDH REAGENT
K843774 · JMK
Reagents Applications, Inc.
Chemistry · 36d
Cleared Oct 31, 1984
TAL-CLIP
K843816 · GDJ
Talboy, Inc.
General & Plastic Surgery · 33d
Cleared Oct 31, 1984
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872 · DKC
Sigma Chemical Co.
Chemistry · 29d
Cleared Oct 31, 1984
O.B. BASIN SET
K843982 · FRG
Pro-Lab, Inc.
General Hospital · 20d
Cleared Oct 31, 1984
AO-10 AUTOMATED OSMOMETER
K843997 · JJM
bioMerieux, Inc.
Chemistry · 20d
Cleared Oct 31, 1984
ONO/CO-TWO (TM) SYSTEMS
K844014 · JTY
Micro-Bio-Logics
Microbiology · 19d
Cleared Oct 31, 1984
STREP ID TRIPLATE
K844019 · JTO
Remel Co.
Microbiology · 16d
Cleared Oct 30, 1984
IMPEDANCE/8200 MONITOR-MODEL 8300
K840358 · KRC
Aequitron Medical, Inc.
Cardiovascular · 278d
Cleared Oct 30, 1984
MUSE-DP
K840932 · DXN
Marquette Electronics, Inc.
Cardiovascular · 242d
Cleared Oct 30, 1984
SCOTT SELECTICULT-HSV ISOLATION &
K841680 · GQL
Scott Laboratories, Inc.
Microbiology · 190d
Cleared Oct 30, 1984
ANTI-SCHISTOSOMA SPECIES KIT
K842660 · GNH
Amico Lab, Inc.
Immunology · 112d
Cleared Oct 30, 1984
EMA LIV CENERA DENTAL CEMENT
K842995 · EMA
Int'L Corp.
Dental · 92d
Cleared Oct 30, 1984
SERVO MED NYSTAGMOGRAPH NG-1
K843004 · GWN
Servo Med, Inc.
Neurology · 92d
Cleared Oct 30, 1984
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K843534 · LAT
Immunalysis Corporation
Toxicology · 53d