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
152041–152064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1984
INORGANIC PHOSPHORUS TEST
K843177 · CEO
Sclavo, Inc.
Chemistry · 32d
Cleared Sep 14, 1984
STREP SELECTIVE II
K843193 · JSI
Remel Co.
Microbiology · 31d
Cleared Sep 14, 1984
V AGAR SELECTIVE DEEPS
K843194 · JSI
Remel Co.
Microbiology · 31d
Cleared Sep 14, 1984
AMIKACIN CALIBRATOR ACA
K843210 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 30d
Cleared Sep 14, 1984
ANSWER ONE-DAY
K843238 · LCX
Armkel, LLC
Chemistry · 23d
Cleared Sep 14, 1984
LIGHT BEAM COLLIMATOR
K843244 · IZW
Dealers X-Ray Co., Inc.
Radiology · 25d
Cleared Sep 14, 1984
TECHNICON RA-1000 SYS IRON FOR SERUM
K843255 · JIY
Technicon Instruments Corp.
Chemistry · 25d
Cleared Sep 14, 1984
T.I.M.E. DISPENSER
K843272 · JTC
Dynatech Laboratories, Inc.
Microbiology · 25d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
ALKALINE PHOSPHATASE REAGENT SET
K843332 · CJE
Sterling Biochemical, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
ETHYL ALCOHOL ASSAY KIT
K843378 · DMT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 17d
Cleared Sep 14, 1984
CORNING HIGH RESOLUTION PROTEIN ELECTRO
K843397 · CEF
Corning Medical & Scientific
Chemistry · 16d
Cleared Sep 14, 1984
EMIT 700 BARBITURATE ASSAY
K843418 · DIS
Syva Co.
Toxicology · 14d
Cleared Sep 14, 1984
GRAM STAIN SET W/STABILIZED IODINE
K843429 · JTS
Accra Laboratories, Inc.
Pathology · 10d
Cleared Sep 13, 1984
JINOTTI OXYGEN/SUCTION CATHETER
K841425 · BSY
Research Medical, Inc.
Anesthesiology · 160d
Cleared Sep 13, 1984
AXIOM STABLE II TRIGLYCERIDES TEST
K842443 · CDT
Axiom, Inc.
Chemistry · 84d
Cleared Sep 13, 1984
INFANT APNEA BED STIMULATOR AA-010
K842607
Alpha Medical Systems
General Hospital · 70d
Cleared Sep 13, 1984
DEKA SOLUTION ADMIN. SET DK 302-A
K843054 · FPA
Deka Research & Development Corp.
General Hospital · 41d
Cleared Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
K843112 · JIT
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Sep 13, 1984
ID ZINE LD ISOENZYME CONTROL ABNORM
K843265 · JJT
Beckman Instruments, Inc.
Microbiology · 24d
Cleared Sep 13, 1984
ID ZONE NORMAL LD ISOENZYME CONTROL
K843266 · JJT
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 24d