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
155185–155208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1984
TECH. RA-1000 SYS SERUM CHLORIDE
K833746 · CHJ
Technicon Instruments Corp.
Chemistry · 79d
Cleared Jan 13, 1984
THERAPEUTIC DRUG CONTROL
K833761 · DKB
Icl Scientific
Toxicology · 79d
Cleared Jan 13, 1984
SHABAN 9865 IL#78637 JUNCTION BLOC
K833804 · JJF
Shaban Mfg. Co.
Chemistry · 73d
Cleared Jan 13, 1984
ARGYLE JET TRACHEAL TUBE
K833807 · BTR
Sherwood Medical Co.
Anesthesiology · 73d
Cleared Jan 13, 1984
INTERAD 520
K833821 · IYX
Interad Systems, Inc.
Radiology · 72d
Cleared Jan 13, 1984
FSH RIA
K833852 · CGJ
Syncor Intl. Corp.
Chemistry · 70d
Cleared Jan 13, 1984
LH RIA
K833854 · CEP
Syncor Intl. Corp.
Chemistry · 70d
Cleared Jan 13, 1984
AMYLASE REAGENT SET-MODIFIED CARAWAY
K833864 · CJA
Sterling Biochemical, Inc.
Chemistry · 67d
Cleared Jan 13, 1984
VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
K833878 · KXT
Vxr, Inc.
Toxicology · 66d
Cleared Jan 13, 1984
ACETABULAR SCREW RING
K833881 · JDI
Mecron Medical Products, Inc.
Orthopedic · 65d
Cleared Jan 13, 1984
TRI-LEVEL BILIRUBIN CONTROLS
K833898 · JJX
Sandare Chemical Co., Inc.
Chemistry · 60d
Cleared Jan 13, 1984
BAC-T-SCREEN
K833917 · JTA
Marion Laboratories, Inc.
Chemistry · 60d
Cleared Jan 13, 1984
UREA NITROGEN-UV
K833931 · CDQ
Seragen Diagnostics, Inc.
Chemistry · 60d
Cleared Jan 13, 1984
TOTAL PROTEIN REAGENT CS-724
K833950 · CEK
Fisher Scientific Co., LLC
Chemistry · 59d
Cleared Jan 13, 1984
PEPTIC DIGEST AGAR
K834020 · JSJ
Micro Media Laboratories
Microbiology · 53d
Cleared Jan 13, 1984
TITERTEK ENTEROBAC*
K834090 · JSS
Flow Laboratories, Inc.
Microbiology · 46d
Cleared Jan 13, 1984
TABLE, MODELS 610,611 & 612
K834103 · INQ
Tri W-G, Inc.
Physical Medicine · 45d
Cleared Jan 13, 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · DXT
Cordis Corp.
Cardiovascular · 45d
Cleared Jan 13, 1984
CHIROPRACTIC ACTIVATOR OR PORT. CHIRO
K834137
Rhode Island Chiropractic Pain Clinic
Physical Medicine · 44d
Cleared Jan 13, 1984
CONCHATHERM LHF HUMIDIFIER HEATER
K834151 · BTT
Respiratory Care, Inc.
Anesthesiology · 43d
Cleared Jan 13, 1984
REVERSE-FLOW SYSTEM
K834264 · JTA
Applied Polytechnology, Inc.
Microbiology · 36d
Cleared Jan 13, 1984
ELECTRONIC CELL ENERGIZER
K834293 · LBG
Electronic Energy, Inc.
Physical Medicine · 36d
Cleared Jan 13, 1984
CAMPY 3
K834313 · JSJ
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
CAMPY 5
K834314 · JSJ
Hardy Media
Microbiology · 35d