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
162265–162288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN M TEST PACK
K812632 · DFT
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633 · CZP
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
EHTOX GASTRIC LAVAGE KIT #2050 & #2070
K812648 · KNT
Ethox Corp.
Gastroenterology & Urology · 12d
Cleared Sep 29, 1981
CEA CONTROL PLASMA
K812658 · DHX
Pacific Hemostasis
Immunology · 11d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · DFH
Dako Corp.
Immunology · 11d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · DEH
Dako Corp.
Immunology · 11d
Cleared Sep 29, 1981
AFB STAIN SET
K812668 · JTS
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Sep 29, 1981
ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE
K812685 · FJK
Ericka
Gastroenterology & Urology · 7d
Cleared Sep 28, 1981
A.D.T. PROCEDURES TRAY
K812297 · KMJ
A.D.T. Lab Industries
General Hospital · 45d
Cleared Sep 25, 1981
SPIROMETER 210/211
K812039 · BZG
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 66d
Cleared Sep 25, 1981
VENTI-MONITOR MODEL 101
K812041 · CAP
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 66d
Cleared Sep 25, 1981
CENTERAL MONITOR 360
K812144 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-3
K812145 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-5
K812146 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-7
K812147 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
DISPOSABLE ELECTRODE, #1610
K812276 · DRX
Andover Medical, Inc.
Cardiovascular · 43d
Cleared Sep 25, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · DYG
Sorensen Research
Cardiovascular · 39d
Cleared Sep 25, 1981
SORENSON SUBCLAVIAN CATHETER SSC-8
K812326 · LFJ
Sorensen Research
Gastroenterology & Urology · 39d
Cleared Sep 25, 1981
KONTRON PMS 7000
K812354 · DQK
Kontron Instruments, Inc.
Cardiovascular · 37d
Cleared Sep 25, 1981
ADAPTIC* C.F.S.
K812449 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 28d
Cleared Sep 25, 1981
EXMOOR AURAL GROMMET AG/TI
K812459 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 25d
Cleared Sep 25, 1981
2000 SERIES PORTABLE RESUSCITATION SYST.
K812519 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
280/4 MINI-DEFIBRILLATOR
K812520 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 23d
Cleared Sep 25, 1981
BEAUFILL
K812545 · EBF
Sci-Pharm, Inc.
Dental · 21d