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
147145–147168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1985
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
K852650 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 53d
Cleared Aug 13, 1985
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
K852665 · JWZ
Syncor Intl. Corp.
Microbiology · 50d
Cleared Aug 13, 1985
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
K852705 · JDI
Waldemar Link GmbH & Co. KG
Orthopedic · 48d
Cleared Aug 13, 1985
GENERAL DIAGNOSTICS COAG-A-MATE XC
K852843 · KQC
Warner-Lambert Co.
Hematology · 39d
Cleared Aug 13, 1985
S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM
K853005 · EGZ
The S. S. White Co.
Dental · 28d
Cleared Aug 13, 1985
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
K853081 · KJK
Advanced Medical Technology, Inc.
Pathology · 21d
Cleared Aug 13, 1985
ECUMOL ULTRAVIOLET SUNTANNNING BEDS
K853177 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 14d
Cleared Aug 13, 1985
PIGGYMATE I.V. TUBING LOCK
K853184 · FPA
Trend Medical, Inc.
General Hospital · 14d
Cleared Aug 13, 1985
ACRIDINE ORANGE FLUORESCENT STAIN
K853187 · IDC
Advanced Medical Technology, Inc.
Pathology · 14d
Cleared Aug 13, 1985
CALCIUM CHLORIDE
K853246 · JPA
Bio/Data Corp.
Hematology · 12d
Cleared Aug 12, 1985
EFFNER-EYE CAUTERY WITH BATTERY HANDLE
K844775 · HQO
Mecron Medical Products, Inc.
Ophthalmic · 245d
Cleared Aug 12, 1985
VISION POTASSIUM
K850950 · CEM
Abbott Laboratories
Chemistry · 158d
Cleared Aug 12, 1985
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU
K851323 · DWF
C.R. Bard, Inc.
Cardiovascular · 130d
Cleared Aug 12, 1985
OCULAR PRESSURE REDUCER (MCCANNEL)
K852032 · LCC
Visitec Co.
Ophthalmic · 95d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
K852176 · GHH
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 84d
Cleared Aug 12, 1985
CEPHALINEX ACTIVATED PTT REAGENT
K852195 · GGW
Bio/Data Corp.
Hematology · 84d
Cleared Aug 12, 1985
VECTOR BAR SUSPENSION/TRACTION UNIT
K852398 · ILZ
Powlan Manufacturing Co.
Physical Medicine · 67d
Cleared Aug 12, 1985
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
K852449 · LZN
Howmedica Corp.
Orthopedic · 63d
Cleared Aug 12, 1985
PLASTINEX
K852484 · GJS
Bio/Data Corp.
Hematology · 62d
Cleared Aug 12, 1985
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
K852519 · JCO
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 56d
Cleared Aug 12, 1985
T-3 RIASSAY
K852537 · CDP
Ria Diagnostics
Chemistry · 59d
Cleared Aug 12, 1985
MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK
K852604 · IRT
Clairol, Inc.
Physical Medicine · 54d
Cleared Aug 12, 1985
HOT PACK
K852610 · IMD
Oriental Medical Supplies, Inc.
Physical Medicine · 54d
Cleared Aug 12, 1985
HUMPHREY IMAGE ANALYZER MODEL 110
K852638 · HKI
Zeiss Humphrey System
Ophthalmic · 53d