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
171745–171768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 13, 1978
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · JLW
Pcl-Ria, Inc.
Chemistry · 34d
Cleared Feb 13, 1978
CPK REAGENT SET
K780070 · CGS
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
HBDH REAGENT SET
K780073 · JMK
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
LDH-L REAGENT SET
K780074
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
CANNULA, ARTERY, RENAL
K780079 · DQR
Dravon Medical, Inc.
Cardiovascular · 28d
Cleared Feb 13, 1978
GLUCOSE REAGENT FOR GLUCOSE ANALYZER
K780093 · CGA
Harleco
Chemistry · 26d