FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150961–150984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1984
VISITEC EYE SPECULUM
K843196 · HNC
Visitec Co.
Ophthalmic · 52d
Cleared Oct 05, 1984
VISITEC EYE SHIELD
K843197 · HMP
Visitec Co.
General & Plastic Surgery · 52d
Cleared Oct 05, 1984
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
K843283 · JJE
Boehringer Mannheim Corp.
Chemistry · 46d
Cleared Oct 05, 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · DHN
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 39d
Cleared Oct 05, 1984
EMIT 700 CANNABINOID CONTROL SET
K843419 · LAS
Syva Co.
Toxicology · 35d
Cleared Oct 05, 1984
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
K843434 · JQC
Iso-Data, Inc.
Chemistry · 31d
Cleared Oct 05, 1984
CILCO DIAMOND KNIFE
K843447 · HNN
Cilco, Inc.
Ophthalmic · 30d
Cleared Oct 05, 1984
CONCEPT FIBER OPTIC CANALICULUS INTUBA
K843491 · HNL
Concept, Inc.
Ophthalmic · 29d
Cleared Oct 05, 1984
EMIT D.A.U. COCAINE ASSAY
K843556 · DIO
Syva Co.
Toxicology · 25d
Cleared Oct 05, 1984
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565 · JJW
Icl Scientific
Chemistry · 25d
Cleared Oct 05, 1984
FIAX HAPTOGLOBIN TEST KIT
K843570 · DAB
Intl. Diagnostic Technology
Immunology · 24d
Cleared Oct 05, 1984
VICO MICRO SURGICAL INSTRUMENTS
K843592 · HWQ
Visitec Co.
Orthopedic · 23d
Cleared Oct 05, 1984
BREATHABLE MINI-SHIELD-PRIVATE LABEL
K843602 · HHD
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 23d
Cleared Oct 05, 1984
EMIT 700 METHAQUALONE ASSAY
K843605 · KXS
Syva Co.
Toxicology · 22d
Cleared Oct 05, 1984
PERSPECTIVE CHEMICAL ANALYZER
K843610 · JJE
American Monitor Corp.
Chemistry · 22d
Cleared Oct 05, 1984
CORNING IMMUNOFIXATION SYS
K843614 · CZP
Corning Medical & Scientific
Chemistry · 21d
Cleared Oct 05, 1984
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679 · DIF
Quantimetrix Corp.
Chemistry · 17d
Cleared Oct 05, 1984
SCLAVO CHLORIDE TEST
K843740 · CHJ
Sclavo, Inc.
Chemistry · 10d
Cleared Oct 04, 1984
ELECTRO-NERVE STIMULATOR HL
K841184 · GZJ
Biomedical Life Systems, Inc.
Neurology · 198d
Cleared Oct 04, 1984
SERVOMED OXYMONITO SMK 363
K842497 · KLK
Litton Datamedix
Anesthesiology · 100d
Cleared Oct 04, 1984
GUIDELINES FOR PEDIATRIC ANESTHESIA
K842610 · CAC
Critical Care Micro Computing
Anesthesiology · 91d
Cleared Oct 04, 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
K842640 · DSI
Spacelabs, Inc.
Cardiovascular · 86d
Cleared Oct 04, 1984
MAXI-MISER HUMIDIFIER INSERT 1020 & 1021
K842794 · BTT
Nova-Ventrx
Anesthesiology · 79d
Cleared Oct 04, 1984
MAXI-MISER HUMIDIFIER INSERT 1030
K842795 · BTT
Nova-Ventrx
Anesthesiology · 79d