FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129865–129888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1989
LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
K893723 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
K893836 · DSH
Quinton Electrophysiology Corp.
Cardiovascular · 107d
Cleared Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · FOZ
Baxter Healthcare Corp
General Hospital · 98d
Cleared Sep 08, 1989
NOETIX, BIOPSY NEEDLE
K893992 · KNW
Noetix, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 08, 1989
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT
K894049 · JLS
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 93d
Cleared Sep 08, 1989
GASTRO ENTEROLOGICAL BIOPTOME
K894419 · KNW
Symbiosis Corp.
Gastroenterology & Urology · 53d
Cleared Sep 08, 1989
LAMANO DIRECTORS
K894592 · GCM
Marlo Surgical Technology
Gastroenterology & Urology · 46d
Cleared Sep 08, 1989
INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
K894612 · NHK
Intertech Resources, Inc.
Anesthesiology · 50d
Cleared Sep 08, 1989
CPAP MASK
K894690 · BYE
Devilbiss Health Care, Inc.
Anesthesiology · 46d
Cleared Sep 08, 1989
DMI SERIES 90 EXAMINATION TABLE
K894788 · KMN
M.D. Intl., Inc.
General Hospital · 42d
Cleared Sep 08, 1989
CEFIXIME 5 MCG SENSITIVITY DISKS
K894829 · JTN
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Sep 08, 1989
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845 · GMD
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Sep 07, 1989
PINSET
K884970 · JKA
Safety Diagnostics, Inc.
Chemistry · 281d
Cleared Sep 07, 1989
ACUDATA INDICATENS MODEL 5M
K890087 · GZJ
Acudata Software
Neurology · 240d
Cleared Sep 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892622 · LYY
Latexon Co., Ltd.
General Hospital · 150d
Cleared Sep 07, 1989
MODIFIED PRISTINE CULTURE CATHETER
K893390 · KOD
Hml Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Sep 07, 1989
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
K893811 · JQW
Sakura Finetek U.S.A., Inc.
Chemistry · 108d
Cleared Sep 07, 1989
ISOLIGHT
K894059 · EAZ
Eurodent, Inc.
Dental · 92d
Cleared Sep 07, 1989
ESSE QUATTRO/ESSE UNO
K894060 · KLC
Eurodent, Inc.
Dental · 92d
Cleared Sep 07, 1989
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · JGY
Sigma Diagnostics, Inc.
Chemistry · 91d
Cleared Sep 07, 1989
DEVON DISPOSABLE HEAD POSITIONER COVER
K894170 · KME
Devon Industries, Inc.
General Hospital · 84d
Cleared Sep 07, 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218 · JGS
Nova Biomedical Corp.
Chemistry · 80d
Cleared Sep 07, 1989
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265 · JLX
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Sep 07, 1989
ACCESS TM
K894290 · LNH
Diasonics, Inc.
Radiology · 76d