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
158089–158112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1982
CLEAR VINYL MONITORING CONNECTOR
K823340 · DXT
Vertex Medical Corp.
Cardiovascular · 52d
Cleared Dec 30, 1982
BENZING RETROGRADE ADMIN. SET
K823373 · FMG
Beech Medical, Inc.
General Hospital · 48d
Cleared Dec 30, 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · DSH
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Dec 30, 1982
MON-A-THERM MYOCARDIAL TEMP. SENSOR
K823435 · KRB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 44d
Cleared Dec 30, 1982
OXYGENATORS #BOS-10, 105, 5S
K823456 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 42d
Cleared Dec 30, 1982
TERUFUSION THREE-WAY STOPCOCK
K823469 · FMG
Terumo Medical Corp.
General Hospital · 38d
Cleared Dec 30, 1982
ENZYMATIC GLUCOSE DETERMINATION
K823474 · CGA
The Dow Chemical Co.
Chemistry · 38d
Cleared Dec 30, 1982
ELECTROCARDIOGRAPH #334
K823488 · DPS
Birtcher Corp.
Cardiovascular · 37d
Cleared Dec 30, 1982
CHOLESTEROL REAGENT
K823500 · CHH
Ac Biochemical Laboratories, Inc.
Toxicology · 36d
Cleared Dec 30, 1982
ESA CAMERA
K823516 · FWH
Concept, Inc.
General & Plastic Surgery · 31d
Cleared Dec 30, 1982
JACKET & SET
K823533 · DTR
Shiley, Inc.
Cardiovascular · 31d
Cleared Dec 30, 1982
IMMUNOGLOBULIN CONTROL
K823566 · CZP
Syva Co.
Chemistry · 27d
Cleared Dec 30, 1982
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
K823567 · CZP
Syva Co.
Immunology · 27d
Cleared Dec 30, 1982
MYOTEST NERVE STIMULATOR
K823583 · BXN
Prothia USA, Inc.
Anesthesiology · 24d
Cleared Dec 30, 1982
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-
K823584 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 24d
Cleared Dec 30, 1982
PICTURES & WORD IDENTIFICATION CVA PAT
K823608 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
ADJ. WOODEN BOARD FOR WRITING
K823612 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
INSULATED THERMOELASTOMER MITT
K823622 · IMA
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
HOLDER FOR MOUTH STICK
K823624 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
MOUTH STICK KIT
K823625 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
DISPOSABLE TOOTH BRUSH
K823626 · ILS
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
FORMED STEEL DEVICE KEEP LEGS SEPARATED
K823629
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
DELUXE KNEE IMMOBILIZER(UNIVERSAL)
K823658 · ITQ
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
PELVIC TRACTION BELT
K823659 · ILZ
Warm & Form, Orthopedic Materials
Physical Medicine · 24d