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
168649–168672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1979
AXIOM FILTERED CONNECTOR
K791508
Axiom Medical, Inc.
General & Plastic Surgery · 34d
Cleared Sep 04, 1979
AXIOM GASTRO SUMP DRAIN
K791509
Axiom Medical, Inc.
General & Plastic Surgery · 34d
Cleared Sep 04, 1979
ENZYMATIC REAGENT SET, 4X250 ML.
K791511 · CHH
Macomb Chemical Co.
Chemistry · 40d
Cleared Sep 04, 1979
SURELOC EXTERNAL CONNECTOR
K791532 · BZA
Polamedco, Inc.
Anesthesiology · 25d
Cleared Sep 04, 1979
ELECTROCARDIOGRAPH MODEL ECG-5403
K791540 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 25d
Cleared Sep 04, 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
K791552 · DTB
Pacesetter Systems
Cardiovascular · 21d
Cleared Sep 04, 1979
IL MODEL END TIDAL CO2 ANALYZER
K791570 · CCK
Instrumentation Laboratory CO
Anesthesiology · 22d
Cleared Sep 04, 1979
JELONET PARAFFIN GAUZE DRESSINGS
K791573 · FRO
Acme United Corp.
General & Plastic Surgery · 25d
Cleared Sep 04, 1979
CEREBRAL FUNCTION MONITOR 870
K791580 · OMA
Applied Medical Research
Neurology · 18d
Cleared Sep 04, 1979
GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
K791605 · DEM
Protos Laboratories
Immunology · 15d
Cleared Sep 04, 1979
KWICK KOOLER
K791675 · IMD
Stahlex Corp.
Physical Medicine · 7d
Cleared Aug 28, 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · DJB
Abbott Laboratories
Microbiology · 263d
Cleared Aug 28, 1979
COMPUTERIZED ELECTRO-OCULOGRAPH
K790637 · HLX
Potomac Medical System
Ophthalmic · 148d
Cleared Aug 28, 1979
STAT
K790893 · HKP
Varian Assoc., Inc.
Ophthalmic · 112d
Cleared Aug 28, 1979
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · HBF
Codman & Shurtleff, Inc.
Neurology · 76d
Cleared Aug 28, 1979
ABCOR CARIES DETECTOR MONITOR
K791133 · LFC
Abcor, Inc.
Dental · 71d
Cleared Aug 28, 1979
APOLLO HEART RATE INDICATOR
K791207 · HCC
Key Tronic Corp.
Neurology · 57d
Cleared Aug 28, 1979
PYROLITE CARBON ENDOSSEOUS DENTAL IMPL
K791237 · DZE
Carbomedics, Inc.
Dental · 53d
Cleared Aug 28, 1979
MICROMEDIC APS2
K791324 · JQW
Micromedic Systems
Chemistry · 43d
Cleared Aug 28, 1979
AIRSTRIP THEATRE WARD DRESSING
K791369 · NAD
Acme United Corp.
General & Plastic Surgery · 35d
Cleared Aug 28, 1979
MINIGRAPH MG-I ELECTROCARDIOGRAPH
K791420 · DPS
Renesco International, Inc.
Cardiovascular · 43d
Cleared Aug 28, 1979
MINISCOPE MS-2B ELECTROCARDIOSCOPE
K791421 · DPS
Renesco International, Inc.
Cardiovascular · 43d
Cleared Aug 28, 1979
DCG-VII ELECTROCARDIOSCANNER
K791424 · DSI
Del Mar Avionics
Cardiovascular · 28d
Cleared Aug 28, 1979
PERITONEAL PAC
K791426 · KDJ
Intermed, Inc.
Gastroenterology & Urology · 33d