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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148393–148416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1985
HALL IRRIGATION SYSTEM
K852143 · GBX
Hall Surgical, Division of Zimmer, Inc.
General & Plastic Surgery · 41d
Cleared Jun 26, 1985
ACKRAD SIALOGRAPHY CATHETER
K852154
Ackrad Laboratories
General & Plastic Surgery · 40d
Cleared Jun 26, 1985
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 26, 1985
SURE-COUNT 15 COUNT NEEDLE COUNTER
K852257
Kleen Test Products
General & Plastic Surgery · 33d
Cleared Jun 25, 1985
PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES
K844894 · JJQ
Slt Labinstruments, Inc.
Chemistry · 190d
Cleared Jun 25, 1985
BHCG-ROCHE EIA
K850727 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 123d
Cleared Jun 25, 1985
G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S
K850851 · ISA
Physio Technology, Inc.
Physical Medicine · 116d
Cleared Jun 25, 1985
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
K850907 · JJT
Cala Diagnostics
Chemistry · 112d
Cleared Jun 25, 1985
CREATININE
K850932 · CGX
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
URIC ACID
K850933 · CDH
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
PHOSPHORUS
K850934 · CEO
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
TOTAL PROTEINS
K850936 · CEK
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
CHOLESTEROL
K850938 · CGO
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
VENOUS RESERVOIR BAG BMR-1600
K851376 · DTN
American Bentley
Cardiovascular · 78d
Cleared Jun 25, 1985
VENUOS RESERVOIR BAG BMR-1900
K851401 · DTN
American Bentley
Cardiovascular · 77d
Cleared Jun 25, 1985
CK/LD ISOENZYMES CONTROLS(HUMAN)
K851520 · JJT
Seragen Diagnostics, Inc.
Chemistry · 71d
Cleared Jun 25, 1985
ELECTROLYTE ANALYZER
K851808 · CEM
Ionetics, Inc.
Chemistry · 71d
Cleared Jun 25, 1985
TANDEM E PAP
K851950 · JFH
Hybritech, Inc.
Chemistry · 53d
Cleared Jun 25, 1985
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
K851990 · JIX
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
CA BUFFER CA DYE
K852002 · CIC
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
MG REAGENT
K852005 · JGJ
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066 · JHJ
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Jun 25, 1985
BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA
K852158 · LCQ
Bioprobe Intl., Inc.
Toxicology · 39d
Cleared Jun 25, 1985
ASSIST CLINICAL CHEMISTRY ANALYZER
K852262 · JJE
Cooper Biomedical, Inc.
Chemistry · 32d