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
151657–151680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1984
ULTRA-VIOLET A SOURCE LIGHT EMITTING
K842575 · FTC
Sola-Tan Intl.
Radiology · 38d
Cleared Aug 10, 1984
SIMULTROPIN RADIOIMMUNOASSAY KIT LH
K842588
Bd Becton Dickinson Vacutainer...
Chemistry · 38d
Cleared Aug 10, 1984
AMER. BIO-SCIENCE LAB T3 REAGENTS
K842590 · CDP
American Bio-Science Laboratories
Chemistry · 38d
Cleared Aug 10, 1984
PFLEX RESPIRATORY MUSCLE EXERCISER
K842634 · BWF
Health Scan, Inc.
Anesthesiology · 35d
Cleared Aug 10, 1984
BATH TUB TRANSFER CHAIR
K842649 · IKN
Guardian Products Co., Inc.
Neurology · 31d
Cleared Aug 10, 1984
WALL GRAB BARS 98130-98136
K842650 · IKX
Guardian Products Co., Inc.
Physical Medicine · 31d
Cleared Aug 10, 1984
RESPIRONICS VENTEASY
K842693 · BTM
Respironics, Inc.
Anesthesiology · 30d
Cleared Aug 10, 1984
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K842711 · DTN
Shiley, Inc.
Cardiovascular · 29d
Cleared Aug 10, 1984
GRAM IODINE
K842733 · HYI
E K Ind., Inc.
Pathology · 28d
Cleared Aug 10, 1984
WRIGHT-GIEMSA QUICK STAIN
K842745 · IAF
E K Ind., Inc.
Pathology · 28d
Cleared Aug 10, 1984
UNSCENTED MENSTRUAL PAD
K842763 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 25d
Cleared Aug 10, 1984
SCENTED MENSTRUAL PAD
K842764 · HHL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 25d
Cleared Aug 10, 1984
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · DQO
American Edwards Laboratories
Cardiovascular · 24d
Cleared Aug 10, 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · DQO
American Edwards Laboratories
Cardiovascular · 24d
Cleared Aug 10, 1984
ALPHACOIL
K842879
Japan Para Science Institute
Neurology · 18d
Cleared Aug 10, 1984
SULFOSALICYLIC ACID, 3% W/V
K842915 · JIQ
E K Ind., Inc.
Chemistry · 16d
Cleared Aug 09, 1984
DOT-A, DOT-AR PXP-E, PXP-ER
K841905 · JWM
Siemens Gammasonics, Inc.
Radiology · 94d
Cleared Aug 09, 1984
RIDGEMATRIX 20/40 MESH, PERIOMATRIX
K842163 · LYC
Orthomatrix, Inc.
Dental · 71d
Cleared Aug 09, 1984
WESCOTT TYPE BIOPSY NEEDLE
K842406
Popper & Sons, Inc.
General & Plastic Surgery · 51d
Cleared Aug 09, 1984
R.L. MEDICAL TWIN LIGHT SOURCE
K842609 · FCW
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 09, 1984
MICROSTAT GAMMA COUNTER
K842902 · JJJ
Micromedic Systems
Toxicology · 17d
Cleared Aug 09, 1984
SICKLE-HEME A/S HETEROZYGOUS CONTROL
K842955 · GHM
Michclone Associates, Inc.
Hematology · 13d
Cleared Aug 08, 1984
LED STIMULATOR LS-05
K834442 · GWE
Teca, Inc.
Neurology · 236d
Cleared Aug 08, 1984
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS
K841295 · BTT
Bow/Parm
Anesthesiology · 132d