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
172585–172608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1978
RESTRAINT, PROTECTIVE
K780232 · FMQ
Biomet, Inc.
General Hospital · 12d
Cleared Feb 17, 1978
EK-670
K780138 · DPS
Burdick Corp.
Cardiovascular · 23d
Cleared Feb 17, 1978
HANDPIECE, LIFT, ENDO
K780213 · EGS
Kerr Corporation (Danbury)
Dental · 9d
Cleared Feb 17, 1978
SPREADER BARS
K780226 · ILZ
Biomet, Inc.
Physical Medicine · 8d
Cleared Feb 17, 1978
COMPRESSION MULTISONIC
K780241 · ESD
Qualitone
Ear, Nose, Throat · 4d
Cleared Feb 16, 1978
PROPHY CUPS, R&R
K780198 · EHK
Ransom and Randolph
Dental · 9d
Cleared Feb 16, 1978
PROPHY ANGLES, R&R
K780199 · EGS
Ransom and Randolph
Dental · 9d
Cleared Feb 16, 1978
ORTHODONTIC BUCCAL TUBE
K780205 · DZD
Rocky Mountain Orthodontics, Inc.
Dental · 9d
Cleared Feb 16, 1978
4-IN-1 DISP. CROWN & BRIDGE TRAY
K780211 · EHY
Kerr Corporation (Danbury)
Dental · 8d
Cleared Feb 14, 1978
CATHETER/HEMOSTATIC/GERIATRIC
K780062 · EZL
Kendall Research Center
Gastroenterology & Urology · 33d
Cleared Feb 14, 1978
BUN REAGNET SET
K780069 · CDQ
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Feb 14, 1978
GAMA-GPT REAGENT SET
K780071 · JQB
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Feb 14, 1978
GLUCOSE REAGENT SET
K780072 · CFR
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Feb 14, 1978
ULTRAZYME PLUS LDH
K780101 · CFJ
Harleco
Chemistry · 25d
Cleared Feb 14, 1978
STRAP, LEGREST
K780191 · KNO
Orthopedic Equipment Co., Inc.
Physical Medicine · 11d
Cleared Feb 14, 1978
LEGREST, ELEVATING
K780192 · KNN
Orthopedic Equipment Co., Inc.
Physical Medicine · 11d
Cleared Feb 14, 1978
HEEL LOOPS
K780193 · KNO
Orthopedic Equipment Co., Inc.
Physical Medicine · 11d
Cleared Feb 14, 1978
TOE LOOPS
K780194 · KNO
Orthopedic Equipment Co., Inc.
Physical Medicine · 11d
Cleared Feb 13, 1978
MONITOR, CARDIAC, BEDSIDE
K772332 · DRT
Telectronics, Inc.
Cardiovascular · 53d
Cleared Feb 13, 1978
RECORDER, PAPER, ECG
K772333 · DSF
Telectronics, Inc.
Cardiovascular · 53d
Cleared Feb 13, 1978
FINGER EXERCISE BOARD
K772404 · ION
Fred Sammons, Inc.
Physical Medicine · 48d
Cleared Feb 13, 1978
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
K772422 · DON
Bio-Rad
Immunology · 47d
Cleared Feb 13, 1978
ESIS MODULE
K780043 · DRR
Datascope Corp.
Cardiovascular · 35d
Cleared Feb 13, 1978
THYROXINE STDS. IN HUMAN SERUM
K780050 · CDX
Pcl-Ria, Inc.
Chemistry · 35d