FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93625–93648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1997
SNT DISPOSABLE BIOPSY NEEDLE
K971247 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 74d
Cleared Jun 16, 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · CFR
Bayer Corp.
Chemistry · 70d
Cleared Jun 16, 1997
SPECIALITY URINE 1,2
K971405 · JJY
Chiron Diagnostics Corp.
Chemistry · 61d
Cleared Jun 16, 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467 · CFR
Carolina Liquid Chemistries Corp.
Chemistry · 55d
Cleared Jun 16, 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
K971709 · KLI
Monobind
Chemistry · 39d
Cleared Jun 16, 1997
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
K971779 · CDP
Monobind
Chemistry · 33d
Cleared Jun 16, 1997
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · LBS
Roche Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
K971952 · JJY
Bio-Rad
Chemistry · 19d
Cleared Jun 16, 1997
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
K972004 · CGZ
Alko Diagnostic Corp.
Chemistry · 17d
Cleared Jun 13, 1997
NYLON COATED SPECULA
K925501 · HIB
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 1687d
Cleared Jun 13, 1997
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
K961779 · BZH
Avion Medical Products, Inc.
Anesthesiology · 401d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · KGI
Hologic, Inc.
Radiology · 400d
Cleared Jun 13, 1997
LXN FRUCTOSAMINE TEST SYSTEM
K962597 · LCP
Lxn Corp.
Chemistry · 346d
Cleared Jun 13, 1997
DEVILBISS 8650D
K963349 · BTI
Devilbiss Health Care, Inc.
Anesthesiology · 291d
Cleared Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 280d
Cleared Jun 13, 1997
MITAYA ALUMINUM INTERSPACED X-RAY GRID
K964025 · IXJ
X-Ray Accessory Corp.
Radiology · 249d
Cleared Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 217d
Cleared Jun 13, 1997
VERIDOSE DIODES
K964785 · IYE
Victoreen, Inc.
Radiology · 196d
Cleared Jun 13, 1997
PEAK FLOW METER
K970507 · BZH
Intl. Medical, Inc.
Anesthesiology · 123d
Cleared Jun 13, 1997
N/A
K970590 · ILY
North American Technical Services Corp.
Physical Medicine · 115d
Cleared Jun 13, 1997
N/A
K970592 · ILY
North American Technical Services Corp.
Physical Medicine · 115d
Cleared Jun 13, 1997
SIMS HYPERINFLATION BAG SYSTEM
K970785 · NHK
Sims
Anesthesiology · 101d
Cleared Jun 13, 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · BTM
Instrumentation Industries, Inc.
Anesthesiology · 88d