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

Filters: Cleared only ×
175,820 results
142105–142128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1986
REFLOTRON(R) ALT (GPT)
K864082 · CKD
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Dec 04, 1986
ENTERAL ADMINISTRATION ADAPTERS
K864182 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 38d
Cleared Dec 04, 1986
E-Z HOLD WITH ADHESIVE BASE.-#4065
K864188 · KNX
John F. Greer Co., Inc.
Gastroenterology & Urology · 38d
Cleared Dec 04, 1986
ULTRA-GEL - #4083
K864189 · EXB
John F. Greer Co., Inc.
Gastroenterology & Urology · 38d
Cleared Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
K864212 · DDX
Instrumentation Laboratory CO
Hematology · 37d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
K864231 · CDT
U. S. Diagnostics, Inc.
Chemistry · 37d
Cleared Dec 04, 1986
SIMPLASTIN EXCEL
K864283 · GJS
Organon Teknika Corp.
Hematology · 35d
Cleared Dec 04, 1986
ZENEX MEDICAL, INC. GAUZE SPONGES
K864298 · EFQ
Zenex Medical, Inc.
General & Plastic Surgery · 34d
Cleared Dec 04, 1986
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389 · LJP
American Micro Scan
Microbiology · 28d
Cleared Dec 03, 1986
SANTEST 1AP
K862087 · LKL
Scientific Sales Intl., Inc.
Immunology · 184d
Cleared Dec 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 125d
Cleared Dec 03, 1986
CHOICE CONDOM
K863190 · HIS
Select Sources, Inc.
Obstetrics & Gynecology · 106d
Cleared Dec 03, 1986
SANDHILL AMS
K863312 · FAP
Sandhill
Gastroenterology & Urology · 99d
Cleared Dec 03, 1986
IMMPULSE IGE ASSAY REAGENTS
K863327 · DGP
Sclavo, Inc.
Immunology · 98d
Cleared Dec 03, 1986
RAPID SPECIFIC IGE PROCEDURE
K863394 · DHB
Allertec, Inc.
Immunology · 91d
Cleared Dec 03, 1986
SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
K863428 · LNK
Laser Media
Gastroenterology & Urology · 90d
Cleared Dec 03, 1986
VIBRATRON II, VIBRATION SENSITIVITY TESTER
K863607 · LLN
Sensortek, Inc.
Neurology · 78d
Cleared Dec 03, 1986
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · FFK
Candela Corp.
Gastroenterology & Urology · 77d
Cleared Dec 03, 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · LJP
Kallestad Laboratories, Inc.
Microbiology · 75d
Cleared Dec 03, 1986
3M IGG4 FAST TEST PACKAGE
K863794 · DHB
3M Company
Immunology · 68d
Cleared Dec 03, 1986
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
K864142 · DGC
United Biotech, Inc.
Immunology · 42d
Cleared Dec 03, 1986
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · KTN
Gamma Biologicals, Inc.
Immunology · 37d
Cleared Dec 03, 1986
MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT
K864329 · KNW
Dlp, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 03, 1986
SEMINAL FLUID COLLECTION KIT(TM)
K864473 · HIS
Apex Technologies, Inc.
Obstetrics & Gynecology · 20d