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
141241–141264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · CGA
Lifescan, Inc.
Chemistry · 114d
Cleared Feb 25, 1987
710 PLUS
K864557 · JQP
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN DENTISTRY
K864655
Glen Whitten, Dds
Neurology · 89d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN OPHTHALMOLOGY
K864656
Glen Whitten, Dds
Neurology · 89d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN NEUROLOGY
K864678
Glen Whitten, Dds
Neurology · 85d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN GENERAL MEDICAL
K864679
Glen Whitten, Dds
Neurology · 85d
Cleared Feb 25, 1987
SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN
K864708 · EBI
Ivoclar USA, Inc.
Dental · 85d
Cleared Feb 25, 1987
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · JLS
Amersham Corp.
Chemistry · 76d
Cleared Feb 25, 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · LJP
Syva Co.
Microbiology · 75d
Cleared Feb 25, 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · FOZ
Quinton, Inc.
General Hospital · 82d
Cleared Feb 25, 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
K864975 · EWG
Laserscope
Ear, Nose, Throat · 65d
Cleared Feb 25, 1987
OSSEOINTEGRATED FIXTURES FOR USE IN DENTAL IMPLANT
K864995 · DZE
Vent-Plant Corporation, Inc.
Dental · 65d
Cleared Feb 25, 1987
THERMAL JACKET FOR I.V. FLUID BAGS
K870113 · KPE
Thermal Medical Systems, Inc.
General Hospital · 44d
Cleared Feb 25, 1987
MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
K870270 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 25, 1987
TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER
K870358 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 27d
Cleared Feb 25, 1987
TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR
K870359 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 27d
Cleared Feb 25, 1987
TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS
K870360 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 27d
Cleared Feb 25, 1987
TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.
K870361 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 27d
Cleared Feb 25, 1987
PAP-PAK CYTOBRUSH KIT
K870398 · HHT
Medical Packaging Corp.
Obstetrics & Gynecology · 23d
Cleared Feb 25, 1987
SMI DIGITRON
K870406 · JQW
American Dade
Chemistry · 22d
Cleared Feb 25, 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472 · FKO
Quinton, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 24, 1987
N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
K864177 · JXA
Cls Co.
Hematology · 123d
Cleared Feb 24, 1987
SUCTION TUBE
K864770 · FFA
New England Surgical Instrument Corp.
Gastroenterology & Urology · 81d
Cleared Feb 24, 1987
MENTOR NIPPLE RECONSTRUCTION DEVICE
K870059
Mentor Corp.
General & Plastic Surgery · 48d