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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
109249–109272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1994
THEREX LOW-PROFILE PORT-TITANIUM
K934802 · LJT
Therex Corp.
General Hospital · 166d
Cleared Mar 22, 1994
AIM SUPRACONDYLAR NAIL
K934962 · HSB
Ace Orthopedic Manufacturing Co.
Orthopedic · 155d
Cleared Mar 22, 1994
FERTILITY PLUS 1, 2, 3
K935219 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 147d
Cleared Mar 22, 1994
DRUGS OF ABUSE CONTROLS
K935285 · DIF
Medical Diagnostic Technologies, Inc.
Toxicology · 139d
Cleared Mar 22, 1994
SYNELISA DHEA-SULFATE
K935469 · JKC
Elias U.S.A., Inc.
Chemistry · 139d
Cleared Mar 22, 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · DHB
Diagnostic Products Corp.
Immunology · 127d
Cleared Mar 22, 1994
CERVICAL SELF-RETAINING RETRACTOR
K935529 · GZT
T. Korossurgical Instruments Corp.
Neurology · 126d
Cleared Mar 22, 1994
ACA PLUS FERRITIN CALIBRATOR
K935543 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 126d
Cleared Mar 22, 1994
SERUM AMMONIA CONTROL
K935606 · JJX
P.T. Meditrol
Chemistry · 123d
Cleared Mar 22, 1994
VIDAS T UPTAKE
K935816 · KHQ
Biomerieux Vitek, Inc.
Chemistry · 110d
Cleared Mar 22, 1994
QUALITY CONTROL MATERIAL (ASSAYED)
K935819 · DKC
Columbia Diagnostics, Inc.
Toxicology · 109d
Cleared Mar 22, 1994
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
K935867 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 106d
Cleared Mar 22, 1994
THEREX LOW PROFILE PORT-TITANIUM MODEL
K936012 · LJT
Therex Corp.
General Hospital · 96d
Cleared Mar 22, 1994
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · HAW
Nomos Corp.
Neurology · 95d
Cleared Mar 22, 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · DIS
Microgenics Corp.
Toxicology · 95d
Cleared Mar 22, 1994
COAXIAL BIOPSY NEEDLE
K936194 · FCG
Bard Gynecology and Radiology
Gastroenterology & Urology · 83d
Cleared Mar 22, 1994
GLYCATED HEMOGLOBIN CALIBRATORS
K936204 · LCP
Primus Corp.
Hematology · 83d
Cleared Mar 22, 1994
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
K940089 · JPK
R&D Systems, Inc.
Hematology · 74d
Cleared Mar 22, 1994
M-K WET SALINE DRESSING
K940110 · FRO
Mason-Keller Corp.
General & Plastic Surgery · 71d
Cleared Mar 22, 1994
PHONIC EAR
K940313 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 57d
Cleared Mar 22, 1994
EXTRUDE
K940379 · ELW
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Mar 22, 1994
ECAT PRT
K940478 · KPS
Cti Pet Systems, Inc.
Radiology · 48d
Cleared Mar 22, 1994
3M XP-2000 X-RAY FILM PROCESSOR
K940558 · IXW
3M Company
Radiology · 43d
Cleared Mar 22, 1994
ASPIR-PULSE(TM) SAF-T-VENT
K940575 · CBT
Sherwood Medical Co.
Anesthesiology · 43d