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
139369–139392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1987
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K872727 · CEP
Serono Diagnostics, Inc.
Chemistry · 28d
Cleared Aug 05, 1987
BINAX IRMA TOTAL BETA-HCG TEST KIT
K872728 · JHI
Binax, Inc.
Chemistry · 28d
Cleared Aug 05, 1987
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · CAC
Shiley, Inc.
Anesthesiology · 20d
Cleared Aug 04, 1987
BIO-PROMPT(TM)
K870568 · HCC
Physical Health Devices, Inc.
Neurology · 175d
Cleared Aug 04, 1987
UNIPORT MODEL SD-60, SD-70
K870950 · LJT
Healthcare Technologies, Inc.
General Hospital · 147d
Cleared Aug 04, 1987
FETAL CARE MONITOR ANTEPARTUM 1500
K871082 · HGM
Pie Data Medical BV
Obstetrics & Gynecology · 139d
Cleared Aug 04, 1987
NOVAMETRIX MODEL 200 MAGSTIM
K871338 · GWF
Novametrix Medical Systems, Inc.
Neurology · 123d
Cleared Aug 04, 1987
COMPRESSION LEGGING DEVICE
K871889 · LLK
A-T Surgical Mfg. Co., Inc.
General Hospital · 81d
Cleared Aug 04, 1987
UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM
K872031 · LNK
Laser Media
Gastroenterology & Urology · 70d
Cleared Aug 04, 1987
PHORESOR II (TM), MODEL PM700
K872040 · EGJ
Motion Control, Inc.
Physical Medicine · 69d
Cleared Aug 04, 1987
STERICAP STOPCOCK
K872066 · FMG
Stericap Systems
General Hospital · 67d
Cleared Aug 04, 1987
STERICAP ASSEMBLY AND REPLACEMENT TRAY
K872067 · FMG
Stericap Systems
General Hospital · 67d
Cleared Aug 04, 1987
SURECATH-ITP PERCUTANEOUS ACCESS KIT
K872149 · LJT
Titan Medical, Inc.
General Hospital · 61d
Cleared Aug 04, 1987
BIOCOMP 2001 BIOFEEDBACK DEVICE
K872495 · HCC
Biofeedback Research Institute, Inc.
Neurology · 41d
Cleared Aug 04, 1987
HARD CONTACT LENS REMOVER. ITEM #289
K872591 · KYE
Magnivision, Inc.
Ophthalmic · 34d
Cleared Aug 04, 1987
ANDOVER ADHESIVE TAPE, SURGICAL
K872593 · KGX
Andover Coated Products, Inc.
General & Plastic Surgery · 34d
Cleared Aug 04, 1987
ANDOVER MOLESKIN
K872594 · KGX
Andover Coated Products, Inc.
General & Plastic Surgery · 34d
Cleared Aug 04, 1987
CUTTER PUREFLO PLUS IV FILTER
K872634 · FPB
Miles Laboratories, Inc.
General Hospital · 29d
Cleared Aug 04, 1987
SOLAR GOLD UVA SUN TANNING BED
K872648 · FTC
An-Mar International, Ltd.
General & Plastic Surgery · 28d
Cleared Aug 04, 1987
ULTRAPAC II SX PLUS (TM)
K872657 · GZJ
Medical Devices, Inc.
Neurology · 28d
Cleared Aug 04, 1987
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
K872735 · HSX
Howmedica Corp.
Orthopedic · 26d
Cleared Aug 04, 1987
MODIFIED CURLCATH
K872787 · GBQ
Quinton, Inc.
General & Plastic Surgery · 22d
Cleared Aug 04, 1987
NON-SKID SHOE COVERS
K872797 · FXP
Abco Dealers, Inc.
General Hospital · 20d
Cleared Aug 04, 1987
STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG
K872806 · EFQ
American Silk Sutures, Inc.
General & Plastic Surgery · 21d