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
139249–139272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1987
DELFIA(TM) THYROXINE (T4) KIT
K871303 · CDX
Lkb Instruments, Inc.
Chemistry · 77d
Cleared Jun 17, 1987
ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
K871449 · KPE
Pa Medical Corp.
General Hospital · 65d
Cleared Jun 17, 1987
LINER OR GSRI-PNF
K871497 · EBI
Gulf South Research Institute
Dental · 62d
Cleared Jun 17, 1987
SAFESIDE(TM) LUMED
K871546 · FOZ
Luther Medical Products, Inc.
General Hospital · 58d
Cleared Jun 17, 1987
THEOPHYLLINE FPIA CONTROLS
K871589 · LAW
Sigma Chemical Co.
Toxicology · 54d
Cleared Jun 17, 1987
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
K871620 · GTZ
Allelix, Inc.
Microbiology · 51d
Cleared Jun 17, 1987
NEO-I TEMPERATURE & CONDUCTIVITY METER
K871708 · FIZ
Automata, Inc.
Gastroenterology & Urology · 47d
Cleared Jun 17, 1987
ADULT PERM-CATH 40CM.
K871749 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 17, 1987
VAN-TEC REUSABLE HELICAL STONE BASKET
K871777 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 42d
Cleared Jun 17, 1987
HELICAL STONE BASKET (DISPOSABLE)
K871779 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 42d
Cleared Jun 17, 1987
LIQUID TDM CONTROLS
K871788 · DIF
Biological Industries
Chemistry · 42d
Cleared Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831 · GTZ
Diagnostic Products Corp.
Microbiology · 37d
Cleared Jun 17, 1987
DIGITAL FEVER THERMOMETER MODEL MC-5
K871888 · FLL
Omron Electronics, Inc.
General Hospital · 34d
Cleared Jun 17, 1987
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER
K871892 · KNK
Technicon Instruments Corp.
Chemistry · 33d
Cleared Jun 17, 1987
PERM-CATH CATHETER KIT
K871942 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 17, 1987
BILATERAL CONTINUOUS PASSIVE MOTION DEVICE
K871981 · BXB
Avec Scientific Design Corp.
Physical Medicine · 26d
Cleared Jun 17, 1987
SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)
K872015 · BSJ
Brigam, Inc.
Anesthesiology · 22d
Cleared Jun 17, 1987
UNI-FAST CREATINE KINASE TEST (CK)
K872029 · JHS
Sclavo, Inc.
Chemistry · 22d
Cleared Jun 17, 1987
KODAK EKTACHEM 700S ANALYZER
K872103 · JJE
Eastman Kodak Company
Chemistry · 16d
Cleared Jun 17, 1987
KODAK EKTACHEM 700P ANALYZER
K872104 · JJE
Eastman Kodak Company
Chemistry · 16d
Cleared Jun 17, 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · KHS
Abbott Laboratories
Chemistry · 16d
Cleared Jun 17, 1987
8000 SERIES GAS CHROMATOGRAPHS
K872122 · KZQ
The Perkin-Elmer Corp.
Toxicology · 15d
Cleared Jun 17, 1987
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
K872177 · CGR
Nuclear Diagnostics, Inc.
Chemistry · 9d
Cleared Jun 16, 1987
LP-3 ELECTROCARDIOGRAPH
K864614 · DPS
Fidelity Medical, Inc.
Cardiovascular · 204d