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
140185–140208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1987
C150-P ECG CABLES
K870926 · DPS
Desco Industries, Inc.
Cardiovascular · 73d
Cleared May 21, 1987
STACHROM PROTEIN C TEST KIT
K871039 · GGP
American Bioproducts Co.
Hematology · 65d
Cleared May 21, 1987
SARNS 9000 HEART-LUNG CONSOLE
K871131 · DTQ
3M Health Care, Sarns
Cardiovascular · 62d
Cleared May 21, 1987
BIOSURGE MODEL OASYS
K871258 · CAC
Biosurge, Inc.
Anesthesiology · 51d
Cleared May 21, 1987
QM300 CALIBRATOR A PACK
K871341 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 21, 1987
QM2/QM300 CONTROL A PACK
K871342 · JJY
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 21, 1987
SILVER STAIN REAGENT SYSTEM
K871476 · LEF
Sigma Chemical Co.
Pathology · 37d
Cleared May 21, 1987
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER
K871625 · DTB
Intermedics, Inc.
Cardiovascular · 24d
Cleared May 21, 1987
GBNA MEDIUM
K871786 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
K862122 · KRY
Coulter Electronics, Inc.
Hematology · 351d
Cleared May 20, 1987
TYPE 316L COTTER WIRE
K864375 · LRN
Winn Hirsch & Assoc.
Orthopedic · 196d
Cleared May 20, 1987
PROPHYLACTIC (CONDOM) MR. JOHNNY
K865106 · HIS
Medelec Intl. Corp.
Obstetrics & Gynecology · 140d
Cleared May 20, 1987
ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2
K870230 · EJJ
Degussa Dental, Inc.
Dental · 119d
Cleared May 20, 1987
ABBOTT TESTPACK HCG COMBO
K870739 · JHI
Abbott Laboratories
Chemistry · 83d
Cleared May 20, 1987
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
K870751 · JHI
Syntron Bioresearch, Inc.
Chemistry · 84d
Cleared May 20, 1987
FAST-PATCH(TM)
K871224 · LDD
Physio-Control Corp.
Cardiovascular · 54d
Cleared May 20, 1987
FOLLICLE STIMULATING HORMONE (HFSH)
K871317 · CGJ
Immuchem Corp.
Chemistry · 48d
Cleared May 20, 1987
IONOCAL
K871562 · EMA
Foremost Dental Mfg., Inc.
Dental · 28d
Cleared May 20, 1987
URINOSCOPY FUNNEL
K871671 · GHO
Portable Medical Laboratories, Inc.
Hematology · 22d
Cleared May 20, 1987
TYTEM(R) REAGENT DISPENSER
K871687 · JQW
Medical Laboratory Automation...
Chemistry · 21d
Cleared May 20, 1987
ARYLSULFATASE BROTH
K871701 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared May 20, 1987
MRS AGAR AND MRS BROTH
K871702 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared May 20, 1987
BLOXOM IRRIGATOR
K871791 · EXD
I.B. Bloxom C/O Hogan & Hartson
Gastroenterology & Urology · 13d
Cleared May 19, 1987
HR-5000 ELECTROSURGICAL DEVICE
K864869 · KCW
Ime Co. , Ltd.
General & Plastic Surgery · 158d