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
171553–171576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1978
REDI-DISC HEMOGLOBIN GEL TUBE KIT
K780163 · JBD
Miles Laboratories, Inc.
Hematology · 55d
Cleared Mar 27, 1978
THROMBOPLASTIN DRIED
K780203 · GJS
Hyland Therapeutic Div., Travenol...
Hematology · 48d
Cleared Mar 27, 1978
SPECTROPHOTOMETER, FLUORESCENCE M.650-10
K780242 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 27, 1978
RECORDER, RE-100P HOT STYLUS STRIP CHART
K780245 · DSF
Waters Assoc., Inc.
Cardiovascular · 42d
Cleared Mar 27, 1978
CELL
K780305 · KJF
Dynatech Laboratories, Inc.
Pathology · 32d
Cleared Mar 27, 1978
I.V. START KIT
K780350 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 24d
Cleared Mar 27, 1978
DEN-Z-ORB
K780400 · KHR
Nice-Pak Products, Inc.
Dental · 14d
Cleared Mar 27, 1978
SUBCLAVIAN TRAY
K780419 · KGO
Concord Laboratories, Inc.
General Hospital · 13d
Cleared Mar 22, 1978
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · DXK
Hewlett-Packard Co.
Radiology · 22d
Cleared Mar 22, 1978
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
K780335 · DBA
Hyland Therapeutic Div., Travenol...
Immunology · 22d
Cleared Mar 22, 1978
MIF PROCEDURE KIT
K780346 · JTS
Marion Laboratories, Inc.
Immunology · 21d
Cleared Mar 22, 1978
T3 UPTAKE TEST
K780361 · KHQ
Monobind
Immunology · 16d
Cleared Mar 22, 1978
SPECTROFLUOROMETER SF-330
K780362 · KHO
Varian Assoc., Inc.
Toxicology · 16d
Cleared Mar 22, 1978
COUNTER, RADIOASSAY, AUTO., MICROMEDIC
K780383 · JJJ
Micromedic Systems
Immunology · 13d
Cleared Mar 22, 1978
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · JJE
Syva Co.
Immunology · 12d
Cleared Mar 22, 1978
SPECTROPHOTOMETER, ABSORPTION, ATOMIC
K780390 · JXR
Varian Assoc., Inc.
Toxicology · 12d
Cleared Mar 22, 1978
NASAL GASTRIC TUBE RETAINER
K780396 · FPK
Mor-Mac, Inc.
General Hospital · 9d
Cleared Mar 22, 1978
ORTHOPEDIC FORCEPS
K780397 · HTX
Orthopedic Equipment Co., Inc.
Orthopedic · 9d
Cleared Mar 22, 1978
MICRONET LIGHT DRESSING SPONGE
K780408 · NAB
Kendall Research Center
General & Plastic Surgery · 9d
Cleared Mar 21, 1978
TELETRACE TELEPHONE EKG TRANSMITTER
K780158 · DXH
Medtronic Vascular
Cardiovascular · 50d
Cleared Mar 21, 1978
PHONIC EAR
K780363 · ESD
Hc Electronics
Ear, Nose, Throat · 15d
Cleared Mar 21, 1978
CUP, ACETABULAR, LONG POSTERIOR WALL
K780398 · JDI
Orthopedic Equipment Co., Inc.
Orthopedic · 8d
Cleared Mar 17, 1978
CANDIDA IMMUNODIFFUSION KIT
K770527 · GMI
I M, Inc.
Microbiology · 364d
Cleared Mar 17, 1978
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
K772362 · FIE
Terumo America, Inc.
Gastroenterology & Urology · 80d