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
153841–153864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1984
VANADIUM EXCAVATORS SIZES 0-6
K834055 · EKC
Henry Schein, Inc.
Dental · 90d
Cleared Feb 21, 1984
INSTRUMENT, DENTAL
K834072 · EMS
Venture Technology, Inc.
Dental · 88d
Cleared Feb 21, 1984
PRE-CALIBRATED PIPETTES
K834100 · JRC
Vitex
Chemistry · 83d
Cleared Feb 21, 1984
HYBRITECH DATA STATION
K834300 · JQP
Hybritech, Inc.
Chemistry · 74d
Cleared Feb 21, 1984
ULTRASOUND SCANNER XL
K834307 · IYO
Interad Systems, Inc.
Radiology · 110d
Cleared Feb 21, 1984
FLOW-PAC CHLORIDE REAGENT SET
K834333 · CHJ
American Research Products Co.
Chemistry · 71d
Cleared Feb 21, 1984
FLOW-PAC CALCIUM REAGENT SET
K834336 · CIC
American Research Products Co.
Chemistry · 71d
Cleared Feb 21, 1984
LEECO T3-QUANT DIAG. KIT
K834348 · CDP
Leeco Diagnostics, Inc.
Chemistry · 70d
Cleared Feb 21, 1984
DIRECT IRON REAGENT SET
K834396 · CFM
Seragen Diagnostics, Inc.
Chemistry · 69d
Cleared Feb 21, 1984
CROWN & BRIDGE RESIN
K834435 · EBI
Rohm and Haas Co.
Dental · 64d
Cleared Feb 21, 1984
SERIES OF DIAGNOSTIC PHANTOMS
K834465 · IXG
Cirs, Inc.
Radiology · 63d
Cleared Feb 21, 1984
CHICK/REISON PATIENT EMERG. TROLLEY
K834478 · KXJ
Professional Medical Products, Inc.
Radiology · 63d
Cleared Feb 21, 1984
CRONEX SR-337
K834484 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 82d
Cleared Feb 21, 1984
FLEXIBLE LIQUID LIGHT GUIDE
K834487 · FFS
Endo Lase, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 21, 1984
SPECTRUM X-RAY CORP
K834494 · IZZ
Spectrum X-Ray Corp.
Radiology · 69d
Cleared Feb 21, 1984
ISOREX LS-36
K834496 · IZI
Elscint, Inc.
Radiology · 75d
Cleared Feb 21, 1984
PROFILE URODYNAMIC MONITORING SYS
K834503 · FAP
Browne Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Feb 21, 1984
SANDMILL RMS
K834512 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 62d
Cleared Feb 21, 1984
MODEL 2001 INTELLIGENT INFUSOR
K834528 · LDR
Quest Medical, Inc.
General Hospital · 62d
Cleared Feb 21, 1984
LAS-2 ALIGNMENT SYSTEM
K834538 · KPO
Therados, Inc.
Radiology · 71d
Cleared Feb 21, 1984
DELUXE WALL-MOUNTED CEPHALOMETER
K834559 · IWY
Knochen Dental Laboratory
Radiology · 55d
Cleared Feb 21, 1984
X-RAY COLLIMATOR X-CJD
K834606 · EHB
Knochen Dental Laboratory
Radiology · 55d
Cleared Feb 21, 1984
ELECTRONIC KVP CASSETTE
K834607 · IWN
Radiation Measurements, Inc.
Radiology · 67d
Cleared Feb 21, 1984
SINGUL-XR RP NON SCREEN MED. FILM
K834611 · IWZ
Cea America Corp.
Radiology · 63d