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
161209–161232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375 · KSA
Coulter Electronics, Inc.
Hematology · 65d
Cleared Feb 04, 1982
ULTRASONIC FRAGMENTOR
K813389 · HQE
Fibra Sonics, Inc.
Radiology · 63d
Cleared Feb 04, 1982
XOMED MICRO-IRRIGATOR
K813475 · FQH
Xomed, Inc.
General Hospital · 65d
Cleared Feb 04, 1982
OMS INFUSION-ASPIRATION HANDLE
K813500 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 52d
Cleared Feb 04, 1982
XEROFORM DRESSING
K813535 · FRO
W.G. Whitney Corp.
General & Plastic Surgery · 49d
Cleared Feb 04, 1982
CTF MODEL 9300
K813588 · IZI
Thomson-Csf Broadcast, Inc.
Radiology · 38d
Cleared Feb 04, 1982
RAPID E
K813609 · JSS
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
RAPID STREP
K813610 · JTO
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
CHE
K813611 · JSC
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
STAPH TRAC
K813614 · JWX
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
CHL
K813615 · JSC
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
STOLTRONICS-LRS
K813637 · KCW
Stoltronic Systems, Inc.
General & Plastic Surgery · 36d
Cleared Feb 04, 1982
PLEUROFIX THORACENTESIS KIT
K820004 · GAZ
Burron Medical Products, Inc.
General Hospital · 31d
Cleared Feb 04, 1982
COMFEEL PROTECTIVE SHEET
K820018 · KGX
Telecam Medical Devices
General & Plastic Surgery · 30d
Cleared Feb 04, 1982
MODIFIED EA 50
K820027 · HZJ
Surgipath
Pathology · 30d
Cleared Feb 04, 1982
CADWELL 5200
K820031 · JXE
Cadwell Laboratories, Inc.
Neurology · 29d
Cleared Feb 04, 1982
SICKLE-CHECK
K820037 · JCM
Diagnostic Technology, Inc.
Hematology · 28d
Cleared Feb 04, 1982
FSH RADIOIMMUNOASSAY TEST SYSTEM
K820048 · CGJ
Monobind
Chemistry · 27d
Cleared Feb 04, 1982
SAFETY PINS
K820052 · LDQ
Stan-Pak Ent.
General & Plastic Surgery · 24d
Cleared Feb 04, 1982
KERLIX FLUFFS
K820053 · NAB
Stan-Pak Ent.
General & Plastic Surgery · 24d
Cleared Feb 04, 1982
ELECTROENCEPHALOGRAPHS EEG-5208,5210
K820066 · GWQ
Nihon Kohden America, Inc.
Neurology · 24d
Cleared Feb 04, 1982
MSI STERNUM ASPIRATION NEEDLE
K820070 · GAA
Creative Research and Mfg., Inc.
General & Plastic Surgery · 23d
Cleared Feb 04, 1982
DRAPE, SURGICAL
K820078 · KKX
James L. Geraci & Associates, Inc.
General Hospital · 23d
Cleared Feb 04, 1982
CODMAN * REUSABLE PERFORATOR
K820087 · HBF
Codman & Shurtleff, Inc.
Neurology · 22d