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
170929–170952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1978
STICK, UTILITY
K781197 · ILW
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
BOARD, SCOOTER
K781198 · KNL
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
HOLDER, CARD, QUAD-QUIP
K781199 · ILT
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
NAIL CLIPPERS, ONE-HANDED
K781200 · ILW
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
BOARD, TRANSFER, FENDER
K781201 · IKX
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
VEST, SUPPORT, TRUNK
K781202 · KNO
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
TRAY, LAP, MOLDED
K781203 · KNO
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
BOOK HOLDER
K781204 · ILP
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
TOILET AID
K781205 · ILS
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
FOOT POSITIONER
K781206 · IQI
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jul 31, 1978
TENS-O-TEST
K781321
Curomatic, Inc.
Cardiovascular
Cleared Jul 28, 1978
BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902
K780622 · DTB
Medtronic Vascular
Cardiovascular · 105d
Cleared Jul 28, 1978
ENDOCARDIAL ATRIAL PACING LEAD, M. 6994
K780623 · DTB
Medtronic Vascular
Cardiovascular · 105d
Cleared Jul 28, 1978
NITE TRAIN'R
K780660 · KPN
Nite Train-R Enterprises, Inc.
Gastroenterology & Urology · 99d
Cleared Jul 28, 1978
GENERATOR, PULSE, DEMAND, MODEL 5996
K780741 · DXY
Medtronic Vascular
Cardiovascular · 88d
Cleared Jul 28, 1978
GENERATOR, PULSE MODELS 5920/5921
K780809 · DXY
Medtronic Vascular
Cardiovascular · 71d
Cleared Jul 28, 1978
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS
K781013 · CHH
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Jul 27, 1978
GENERATOR, PULSE, CARDIAC, IMPLANTABLE
K780420 · DXY
Telectronics, Inc.
Cardiovascular · 134d
Cleared Jul 27, 1978
QUANTITATIVE DETERMINATION OF PORPHYRINS
K780455 · JKJ
Whale Scientific, Inc.
Chemistry · 129d
Cleared Jul 27, 1978
VENTRICULAR INHIBITED PULSE GENERATOR
K780561 · DXY
Medtronic Vascular
Cardiovascular · 111d
Cleared Jul 27, 1978
HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2
K780652 · JKS
The London Co.
Hematology · 101d
Cleared Jul 27, 1978
INTRAORAL DENTAL X-RAY GENERATOR
K780742 · IZO
Siemens Corp.
Radiology · 87d
Cleared Jul 27, 1978
O2 CONNECTOR
K780750 · CAN
Diemolding Corp.
Anesthesiology · 80d
Cleared Jul 27, 1978
(125 I) DIGITOXIN RIA KIT
K780766 · LCW
Diagnostic Products Corp.
Toxicology · 83d