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
126193–126216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1990
S-70 PORTABLE DENTAL X-RAY SYSTEM
K894935 · EHD
Lorad Medical Systems, Inc.
Radiology · 265d
Cleared Apr 25, 1990
SAFE AID DEVICE IMPOTENCE DEVICE
K896357 · LKY
Dr. John P. March
Gastroenterology & Urology · 170d
Cleared Apr 25, 1990
HAEMOTRONIC BLOOD LINE SET
K896407 · FJK
Healthcare Suppliers, Inc.
Gastroenterology & Urology · 169d
Cleared Apr 25, 1990
STRATO INDWELLING CATHETER
K896598 · LJS
Strato Medical Corp.
General Hospital · 155d
Cleared Apr 25, 1990
LATEX DENTAL & EXAMINATION GLOVES
K896881 · LYY
American Intl. Health Industries...
General Hospital · 138d
Cleared Apr 25, 1990
NEOPHOR-MC
K900363 · EGJ
L.S. Scientific
Physical Medicine · 90d
Cleared Apr 25, 1990
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618 · KNG
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 76d
Cleared Apr 25, 1990
FLUID SOAKERSHIELD
K900643 · KME
Infection Control Products, Inc.
General Hospital · 75d
Cleared Apr 25, 1990
WORKING CHANNEL VALVE
K900781 · FFY
Applied Urology, Inc.
Gastroenterology & Urology · 64d
Cleared Apr 25, 1990
DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S
K900803 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared Apr 25, 1990
BLOOD GAS CALIBRATION STANDARD
K900819 · LCH
Cryogenic Rare Gas Laboratories, Inc.
Chemistry · 63d
Cleared Apr 25, 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · LCM
Abbott Laboratories
Toxicology · 56d
Cleared Apr 25, 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · EJF
Ivoclar North America, Inc.
Dental · 50d
Cleared Apr 25, 1990
FILLOCK REAMER
K901097 · DZA
Ivoclar North America, Inc.
Dental · 49d
Cleared Apr 25, 1990
PROTOCOL (ALLOY)
K901099 · EJS
Ivoclar North America, Inc.
Dental · 49d
Cleared Apr 25, 1990
STERILE LATEX PATIENT EXAMINATION GLOVES
K901116 · LYY
Medi Tex, Inc.
General Hospital · 47d
Cleared Apr 25, 1990
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
K901241 · LNH
Medical Advances, Inc.
Radiology · 41d
Cleared Apr 25, 1990
WIRONTOM CLASP WIRE
K901257 · EJW
Ivoclar North America, Inc.
Dental · 41d
Cleared Apr 25, 1990
COULTER TOTAL BILIRUBIN REAGENT
K901266 · CIG
Coulter Corp.
Chemistry · 40d
Cleared Apr 25, 1990
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY
K901298 · CGX
Olympus Corp.
Chemistry · 36d
Cleared Apr 25, 1990
HYDRA VIEW IMAGING SYSTEM
K901323 · JAA
Mallinckrodt Group, Inc.
Radiology · 35d
Cleared Apr 25, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · KNK
Technicon Instruments Corp.
Chemistry · 14d
Cleared Apr 25, 1990
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · CKA
American Research Products Co.
Chemistry · 13d
Cleared Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · DQO
C.R. Bard, Inc.
Cardiovascular · 256d