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
166201–166224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1980
EMIT-STM BARBITURATE ASSAY
K802617 · DIS
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL URINE CONTROLS
K802618 · DKC
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
DRUG DETECTION SYSTEM
K802619 · JJQ
Syva Co.
Chemistry · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR
K802620 · DNN
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL ASSAY
K802621 · DMT
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
STERI-SLEEVE
K802629 · DQO
Cordis Corp.
Cardiovascular · 8d
Cleared Oct 28, 1980
L-15T ENDOCARDIAL PACING ELECTRODE
K802689
Coratomic, Inc.
Cardiovascular
Cleared Oct 27, 1980
EMPTY TRANSFER BAGS
K802671
Delmed, Inc.
General & Plastic Surgery
Cleared Oct 27, 1980
OCCUPAK CAT.#200-0538
K802691
Occumedics, Inc.
Ophthalmic
Cleared Oct 23, 1980
PACEPATH MODEL 819
K801417 · DTB
Pacesetter Systems
Cardiovascular · 129d
Cleared Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
K801455 · DTB
Pacesetter Systems
Cardiovascular · 121d
Cleared Oct 23, 1980
COMBOSTAT - NO-BOIL KIT
K801578 · CDD
Ria Products, Inc.
Hematology · 106d
Cleared Oct 23, 1980
VITAMIN B12 - NO-BOIL KIT
K801579 · CDD
Ria Products, Inc.
Hematology · 106d
Cleared Oct 23, 1980
GAMMA COAT(125 I) RUBELLA ANTIBODY
K801667 · GOL
Clinical Assays, Inc.
Microbiology · 94d
Cleared Oct 23, 1980
U.I. OCTOSON
K801675 · LEJ
Ausonics Pty , Ltd.
Radiology · 93d
Cleared Oct 23, 1980
IMED DROP RATE CALCULATOR #340
K801734 · FLN
Imed Corp.
General Hospital · 90d
Cleared Oct 23, 1980
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.
K801792 · DTB
Telectronics, Inc.
Cardiovascular · 86d
Cleared Oct 23, 1980
UNIVERSAL TEMP. PACING ELECT. #080-10000
K801800 · LDF
Medical Testing System, Inc.
Cardiovascular · 86d
Cleared Oct 23, 1980
TENCKHOFF CATHETER
K801818 · FJS
Sil-Med Corp.
Gastroenterology & Urology · 84d
Cleared Oct 23, 1980
MEDELA ELECTRIC BREAST PUMP
K801862 · HGX
Medela, Inc.
Obstetrics & Gynecology · 79d
Cleared Oct 23, 1980
KLINAR REAGENT PAK, #36010
K801892 · JGT
Hi Chem, Inc.
Chemistry · 76d
Cleared Oct 23, 1980
TEMP STERNUM SAW
K801914 · DWI
Temp Medical Products, Inc.
General & Plastic Surgery · 73d
Cleared Oct 23, 1980
MULTICHANNEL TELEMETRY SYSTEM
K801944 · DRG
Burdick Corp.
Cardiovascular · 70d
Cleared Oct 23, 1980
EXTERNAL, TEMP. PORTABLE CARDIAC GENER
K801953 · DTE
Telectronics, Inc.
Cardiovascular · 66d