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
80857–80880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Boston Scientific Corp
Cardiovascular · 239d
Cleared Sep 26, 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · DXQ
Cas Medical Systems, Inc.
Cardiovascular · 223d
Cleared Sep 26, 2000
DRX HBA1C - FOR PRESCRIPTION HOME USE
K000885 · LCP
Metrika, Inc.
Hematology · 190d
Cleared Sep 26, 2000
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
K001022 · JZG
Biocheck, Inc.
Immunology · 180d
Cleared Sep 26, 2000
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
K001244 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 161d
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Dade Behring, Inc.
Immunology · 119d
Cleared Sep 26, 2000
JET 1 POWERED WHEELCHAIR
K001970 · ITI
Pride Mobility Products Corp.
Physical Medicine · 90d
Cleared Sep 26, 2000
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
K002030 · MWI
Invivo Research, Inc.
Cardiovascular · 85d
Cleared Sep 26, 2000
FREEZER TEETHER
K002066 · KKO
Cool Baby, Inc.
Dental · 81d
Cleared Sep 26, 2000
ATAC PAK ALP REAGENT KIT
K002285 · CJE
Elan Diagnostics
Chemistry · 62d
Cleared Sep 26, 2000
SUPER 6
K002300 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
SUPER 14
K002302 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · KHS
Diagnostic Chemicals , Ltd.
Toxicology · 55d
Cleared Sep 26, 2000
CLOUD CUFF
K002360 · DXQ
Parts Port, Ltd.
Cardiovascular · 54d
Cleared Sep 26, 2000
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
K002461 · EMA
Shofu Dental Corp.
Dental · 47d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541 · GGP
Dade Behring, Inc.
Hematology · 41d
Cleared Sep 26, 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL...
K002770 · LJT
Hdc Corp.
General Hospital · 20d
Cleared Sep 26, 2000
KETAC CEM U
K002793 · EMA
Espe Dental AG
Dental · 19d
Cleared Sep 25, 2000
LIPIDURE REWETTING DROPS
K000975 · MRC
Nof Corp.
Ophthalmic · 182d
Cleared Sep 25, 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
K001874 · LJS
Utah Medical Products, Inc.
General Hospital · 97d
Cleared Sep 25, 2000
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL...
K001958 · MPB
Keystone Medical
Gastroenterology & Urology · 90d
Cleared Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 88d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · LBI
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
K002865 · JJS
Bio-Rad
Chemistry · 12d