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
144457–144480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1986
MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE
K861816 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED
K861817 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
K861823 · JSK
Flow Laboratories, Inc.
Microbiology · 8d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
K861824 · JSK
Flow Laboratories, Inc.
Microbiology · 8d
Cleared May 19, 1986
GORE-TEX PERIODONTAL MATERIAL
K854299 · NPK
W.L. Gore & Associates, Inc.
Dental · 206d
Cleared May 19, 1986
SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG
K854737 · FQH
Orthopaedic Devices , Ltd.
General Hospital · 174d
Cleared May 19, 1986
THERAPY CASSETTS
K854920 · MCU
Alpha Therapeutic Corp.
Cardiovascular · 160d
Cleared May 19, 1986
FETASCAN 1500
K860295 · HGM
International Biomedics, Inc.
Obstetrics & Gynecology · 111d
Cleared May 19, 1986
LUNDERQUIST - RING PTC DRAINAGE CATHETER
K861220 · FGE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 48d
Cleared May 19, 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · DTB
Pacesetter Systems
Cardiovascular · 28d
Cleared May 19, 1986
SPIROMETRY MODULE
K861486 · BTY
Medical Graphics Corp.
Anesthesiology · 27d
Cleared May 19, 1986
WECK CONCENTRATED LIQUID CLEANER
K861587 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 20d
Cleared May 19, 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · JJQ
Pharmacia, Inc.
Immunology · 20d
Cleared May 19, 1986
SUPERLON (UNILON) CARBOXYLATE CEMENT
K861685 · EMA
Carlisle Laboratories, Inc.
Dental · 17d
Cleared May 16, 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · DXN
Critikon Company, LLC
Cardiovascular · 192d
Cleared May 16, 1986
PULSE OXIMETER
K855027 · DQA
Physio-Control Corp.
Anesthesiology · 151d
Cleared May 16, 1986
MODEL 535 NEO-TRAK RECORDER
K855045 · DSF
Ge Medical Systems Information...
Cardiovascular · 150d
Cleared May 16, 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · LCP
Pointe Scientific, Inc.,
Hematology · 91d
Cleared May 16, 1986
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
K860923 · GTZ
Self Care Systems, Inc.
Microbiology · 66d
Cleared May 16, 1986
CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)
K861198
Quali-Med, Inc.
General & Plastic Surgery · 46d
Cleared May 16, 1986
PROTEIN C CONTROL PLASMA
K861216 · GGP
American Bioproducts Co.
Hematology · 46d
Cleared May 16, 1986
ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH
K861268 · HRX
Orthopedic Systems, Inc.
Orthopedic · 46d
Cleared May 16, 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · DPS
Hewlett-Packard Co.
Cardiovascular · 36d
Cleared May 16, 1986
MODIFIED UNISCEPT KB LABELING AMENDMENT
K861408 · JWY
Analytab Products, Inc.
Microbiology · 31d