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
135433–135456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1988
SPECTROLYSE/FIBRIN
K881037 · GGP
Cytrx Biopool, Ltd.
Hematology · 112d
Cleared Jul 01, 1988
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
K881113 · JJY
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Jul 01, 1988
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
K881165 · IEO
Sakura Finetek U.S.A., Inc.
Pathology · 103d
Cleared Jul 01, 1988
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231 · BZE
Intertech Resources, Inc.
Anesthesiology · 101d
Cleared Jul 01, 1988
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
K881635 · HQC
Noetix, Inc.
Ophthalmic · 78d
Cleared Jul 01, 1988
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · KYG
Alcon Laboratories
Ophthalmic · 73d
Cleared Jul 01, 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K
K881795 · IZO
Shimadzu Precision Instruments, Inc.
Radiology · 65d
Cleared Jul 01, 1988
PAT PLATELET AGGREGATION TEST
K881829 · JBX
Streck Laboratories, Inc.
Hematology · 63d
Cleared Jul 01, 1988
DS-200 AND DS-400 T.E.N.S.
K881832 · GZJ
Delta Marketing, Inc.
Neurology · 63d
Cleared Jul 01, 1988
BODAI M.D.D. ADAPTOR(TM)
K881849 · BZA
B&B Medical Technologies, Inc.
Anesthesiology · 60d
Cleared Jul 01, 1988
PROSTHODENT VL
K881903 · EBF
Lee Pharmaceuticals
Dental · 56d
Cleared Jul 01, 1988
SPECIFIC CHEMISTRY ANALYZER
K882081 · JJE
The Rupp & Bowman Co.
Chemistry · 45d
Cleared Jul 01, 1988
HEMOGLOBIN SCREENING DEVICE
K882101 · KSL
Portable Medical Laboratories, Inc.
Hematology · 51d
Cleared Jul 01, 1988
SITE ULTRASONIC I/A PHACO NEEDLE
K882103 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 43d
Cleared Jul 01, 1988
MINIFUGE, MODEL 70
K882149 · GPG
Utah Bioresearch, Inc.
Hematology · 39d
Cleared Jul 01, 1988
BIOTROL TOTAL PROTEIN H.P.
K882189 · CEK
Biotrol, USA, Inc.
Chemistry · 38d
Cleared Jul 01, 1988
NIDEK ARK-2000
K882191 · HKO
Nidek, Inc.
Ophthalmic · 38d
Cleared Jul 01, 1988
SIMPLASTIN EXCEL S
K882214 · GJS
Organon Teknika Corp.
Hematology · 36d
Cleared Jul 01, 1988
CANON AUTOREFRACTOMETER R-20
K882287 · HKO
Canon USA, Inc.
Ophthalmic · 30d
Cleared Jul 01, 1988
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · KLB
Syva Co.
Toxicology · 29d
Cleared Jul 01, 1988
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · CHP
Terumo Medical Corp.
Chemistry · 24d
Cleared Jul 01, 1988
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007
K882495 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 15d
Cleared Jul 01, 1988
DISTOMETER
K882575 · HMM
Hagg-Streit Service, Inc.
Ophthalmic · 9d
Cleared Jun 30, 1988
VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM
K881349 · GEH
Cryosurg, Inc.
General & Plastic Surgery · 92d