Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
166561–166584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1980
SUTURE REMOVAL SET CAT.#906
K802019 · KDD
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
PEDIBAND CAT.#195-197
K802021 · NAD
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
STERILE GUAZE SWABS CAT.#301-420
K802022 · EFQ
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
3390A REPORTING INTEGRATOR
K802031 · LDM
Hewlett-Packard Co.
Toxicology · 26d
Cleared Sep 16, 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS824
K802042 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 28d
Cleared Sep 16, 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS843
K802043 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 28d
Cleared Sep 16, 1980
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046 · BZQ
General Electric Co.
Anesthesiology · 22d
Cleared Sep 16, 1980
NIMETIC-DISPERS
K802049 · EBF
Espe Dental Products
Dental · 22d
Cleared Sep 16, 1980
TACKMER INCISE DRAPE
K802050 · KKX
American Convertors Div., American...
General Hospital · 22d
Cleared Sep 16, 1980
OXYGEN SUPPLY TUBING
K802071 · BYX
Auburn Components
Anesthesiology · 20d
Cleared Sep 16, 1980
MUELLER STRETCH M TAPE
K802073 · KGX
Mueller Chemical Co.
General & Plastic Surgery · 20d
Cleared Sep 16, 1980
HOLLOW FIBER DIALYZER HOLDER
K802075 · FKI
Renal Devices, Inc.
Gastroenterology & Urology · 20d
Cleared Sep 16, 1980
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · DWS
Howmedica Corp.
Cardiovascular · 19d
Cleared Sep 16, 1980
CATHETER INSERTION TRAY
K802083 · KOD
Walpak Co.
Gastroenterology & Urology · 18d
Cleared Sep 16, 1980
INTRACRANIAL PRESSURING MONITORING SYST.
K802100 · GWM
Pudenz-Schulte Medical Research Corp.
Neurology · 13d
Cleared Sep 16, 1980
I.V. SENTRY ALARM DEVICE
K802101 · FLN
Pike Medical Co.
General Hospital · 13d
Cleared Sep 16, 1980
C-SPLINT
K802104 · IQI
Cutter Laboratories, Inc.
Physical Medicine · 13d
Cleared Sep 16, 1980
C-BLADE
K802105 · HWE
Cutter Laboratories, Inc.
Orthopedic · 13d
Cleared Sep 16, 1980
SHILEY UTILITY RESERVOIR
K802119 · DTN
Shiley, Inc.
Cardiovascular · 12d
Cleared Sep 16, 1980
MONOSPHERICAL SHOULDER PROSTHESIS
K802123 · HSD
Howmedica Corp.
Orthopedic · 12d
Cleared Sep 16, 1980
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802125 · EBF
Dentsply Intl.
Dental · 12d
Cleared Sep 16, 1980
BACITRACIN DIFFERENTIATION DISC
K802127 · JTO
Biomedia, Inc.
Microbiology · 13d
Cleared Sep 16, 1980
SHILEY TEMPERATURE MONITOR
K802147 · FLL
Shiley, Inc.
General Hospital · 11d
Cleared Sep 16, 1980
COMPOSITE RESTORATIVE
K802262
L.D. Caulk Co.
Dental