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
124201–124224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
K903527 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Sep 27, 1990
LASER CANE
K903558 · HPG
Nurion Industries
Ophthalmic · 50d
Cleared Sep 27, 1990
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · LIT
North American Instrument Corp.
Cardiovascular · 59d
Cleared Sep 27, 1990
SYNERMED URIC ACID REAGENT KIT
K903727 · KNK
Synermed, Inc.
Chemistry · 42d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
K903824 · DKZ
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM
K903825 · DIS
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 27, 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · JIX
Hichem Diagnostics
Chemistry · 36d
Cleared Sep 27, 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · JIX
Baxter Healthcare Corp
Chemistry · 34d
Cleared Sep 27, 1990
GEN-PROBE LUMINOMETER-LEADER 50
K903934 · JJQ
Gen-Probe, Inc.
Chemistry · 31d
Cleared Sep 27, 1990
GARDOSI BIRTHING CUSHION
K903973 · KNC
Graphic Controls Corp.
Obstetrics & Gynecology · 30d
Cleared Sep 27, 1990
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT
K904030 · CJE
Synermed, Inc.
Chemistry · 27d
Cleared Sep 27, 1990
CEDIA TOTAL T3 ASSAY
K904098 · CDP
Microgenics Corp.
Chemistry · 21d
Cleared Sep 27, 1990
REFLOTRON CREATINE KINASE TEST TABS
K904102 · CGS
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Sep 27, 1990
IRON 5 X CONC REAGENT
K904116 · JMO
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 27, 1990
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 15d
Cleared Sep 26, 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · DTB
Medtronic Vascular
Cardiovascular · 147d
Cleared Sep 26, 1990
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
K902091 · LIT
Schneider Intl., Ltd.
Cardiovascular · 140d
Cleared Sep 26, 1990
PERCUTANEOUS INTRODUCER SET
K902275 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 128d
Cleared Sep 26, 1990
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
K902552 · HGY
Gerber Products Co.
Obstetrics & Gynecology · 110d
Cleared Sep 26, 1990
STICK-GARD STERILE CAP
K902682 · LDQ
Integrated Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Sep 26, 1990
LAB-SITE SAFETY NEEDLE
K902881 · CBT
Migada, Ltd.
Anesthesiology · 86d
Cleared Sep 26, 1990
FDI 2000 ULTRASONIC SKIN SCANNER
K902965 · IYO
Fulmer Dyson Intl.
Radiology · 82d
Cleared Sep 26, 1990
TWIN BALLOON INJECTOR
K902975 · LKF
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 82d
Cleared Sep 26, 1990
MICRO BRIGHT VENTILATION TUBES
K903285 · ETD
Invotec International, Inc.
Ear, Nose, Throat · 64d