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
158905–158928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1982
GLUCOSCAN TEST STRIPS
K822697 · CGA
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 30, 1982
GLUCOSCAN CONTROLS
K822698 · JJX
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 30, 1982
V AGAR
K822702 · JSH
Granite Diagnostics, Inc.
Microbiology · 23d
Cleared Sep 30, 1982
PLATELET CENTRIFUGE
K822715 · JQC
Biodynamics Corp.
Hematology · 23d
Cleared Sep 30, 1982
UNIVERSAL CENTRIFUGE
K822716 · JPI
Biodynamics Corp.
Hematology · 23d
Cleared Sep 30, 1982
CROWN S BRIDGE RESIN
K822722 · EBG
Rohm and Haas Co.
Dental · 23d
Cleared Sep 30, 1982
THE SCREENING TYMPANOMETER
K822745 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 20d
Cleared Sep 30, 1982
DELIVERY TUBE SET #2226
K822761 · FRN
Delta Medical Industries
General Hospital · 16d
Cleared Sep 30, 1982
NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT
K822792 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 15d
Cleared Sep 30, 1982
MEDICAL LABS FETAL SCAN #1000 W/CENTRAL
K822830 · HGM
Cranbury Medical Labs, Inc.
Obstetrics & Gynecology · 9d
Cleared Sep 29, 1982
UNKNOWN
K827454
Ote Biomedica
Radiology · 57d
Cleared Sep 29, 1982
STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
K827583 · IWB
Nucletronix, Inc.
Radiology · 30d
Cleared Sep 29, 1982
ULTRASONIC PULSED ECHO IMAGING SYSTEM RT30
K827891
General Electric Co.
Radiology · 49d
Cleared Sep 29, 1982
VRT TABLE
K827928 · IZZ
General Electric Co.
Radiology · 43d
Cleared Sep 29, 1982
ADR ULTRASOUND MC2 LARGE CART
K828049
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
ADR ULTRASOUND MODEL 4000 L
K828050
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC
K828051
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER
K828053
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
UV-A AND UV-B FLUORESCENT LAMPS
K828054
Zip Tan
Radiology · 60d
Cleared Sep 29, 1982
MAMMOMAT B AND BE
K828055
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 29, 1982
MODEL 4045 RADIONUCLIDE CALIBRATOR
K828249
Radcal Corp.
Radiology · 19d
Cleared Sep 28, 1982
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
K821772 · HBL
Downs Surgical , Ltd.
Neurology · 104d
Cleared Sep 28, 1982
MULTIPLE LEAD ARRHYTHMIA MODULE
K822030 · DSI
Marquette Electronics, Inc.
Cardiovascular · 78d
Cleared Sep 28, 1982
FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS
K822265 · EBA
Kelleher Corp.
Dental · 61d