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
164617–164640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1981
CREATINE KINASE REAGENT
K803301 · CGS
Gilford Diagnostics
Chemistry · 17d
Cleared Jan 16, 1981
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305 · JJT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 17d
Cleared Jan 16, 1981
VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
K803309 · DPS
Advanced Technology Laboratories, Inc.
Cardiovascular · 17d
Cleared Jan 16, 1981
'NO-BOIL' DUALCOUNT KIT
K810001 · CGN
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 16, 1981
'NO-BOIL' VITAMIN B12 KIT
K810002 · CDD
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 16, 1981
ALP-KII
K810008 · DXQ
Martin'S Maine Exchange
Cardiovascular · 11d
Cleared Jan 16, 1981
FETAL BLOOD SAMPLING KIT MODEL 1560
K810028 · HGW
Transidyne General Corp.
Obstetrics & Gynecology · 10d
Cleared Jan 15, 1981
CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
K802406 · FMF
Applied Medical Devices, Inc.
General Hospital · 104d
Cleared Jan 15, 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802437 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 101d
Cleared Jan 15, 1981
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
K802801 · KPS
General Electric Co.
Radiology · 70d
Cleared Jan 15, 1981
SCANLAN VASCU-STATT
K802829 · FMP
Scanlan Intl., Inc.
General Hospital · 66d
Cleared Jan 15, 1981
L.A.F. ISOLATION PACK
K802885 · FYA
Action Medical Systems, Inc.
General Hospital · 59d
Cleared Jan 15, 1981
MULTI-IMAGE CAMERA-#627 TLC
K802905 · IYO
Dunn Systems, Inc.
Radiology · 59d
Cleared Jan 15, 1981
SUPER-SPIKE TRANSFER SET
K802940 · KSB
Geneva Laboratories, Inc.
Hematology · 57d
Cleared Jan 15, 1981
POSITIVE END EXPIRATORY PRESSURE VALVE
K802943 · BYE
Fraser Harlake, Inc.
Anesthesiology · 57d
Cleared Jan 15, 1981
DUAL-TROL
K802972 · GEI
Cimarron Instruments, Inc.
General & Plastic Surgery · 55d
Cleared Jan 15, 1981
BONE-DRI SURGICAL SPONGE
K803125 · NAB
Howmedica Corp.
General & Plastic Surgery · 34d
Cleared Jan 15, 1981
LKB-WALLACE 1250 LUMINOMETER
K803131 · JJQ
Lkb Instruments, Inc.
Hematology · 34d
Cleared Jan 15, 1981
SURGITEK MEDI-LOOPS
K803156 · KDC
Medical Engineering Corp.
General & Plastic Surgery · 34d
Cleared Jan 15, 1981
IRRADIATED BOUNDARY DEVICES
K803158 · FYA
The Buckeye Cellulose Corp.
General Hospital · 55d
Cleared Jan 15, 1981
GAUZE SPONGES
K803172 · EFQ
Worldwide Surgical Gauze
General & Plastic Surgery · 31d
Cleared Jan 15, 1981
GAUZE SPONGES
K803188 · GDY
Abco Dealers, Inc.
General & Plastic Surgery · 30d
Cleared Jan 15, 1981
IRRIGATION SET W/PISTON SYRINGE
K803198 · FMF
Walpak Co.
General Hospital · 29d
Cleared Jan 15, 1981
SUTURE REMOVAL KIT
K803199 · KDD
Walpak Co.
General & Plastic Surgery · 29d