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
116665–116688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1992
DIASTAT ANTI-HISTONE KIT
K920616 · LJM
Shield Diagnostics, Ltd.
Immunology · 154d
Cleared Jul 14, 1992
AMRAD HEL-PTEST
K920827 · LYR
Amrad
Microbiology · 141d
Cleared Jul 14, 1992
NK MEDICAL MICROMETER, MODEL MC001
K921266 · KTZ
Nk Biotechnical Engineering Co.
Orthopedic · 120d
Cleared Jul 14, 1992
NK DYNA-GRIP SENSOR, MODEL DG001
K921268 · LBB
Nk Biotechnical Engineering Co.
Neurology · 120d
Cleared Jul 14, 1992
ESP BLOOD CULTURE SYSTEM
K921637 · MDB
Difco Laboratories, Inc.
Microbiology · 99d
Cleared Jul 14, 1992
ENDOBAG, MODIFICATION
K921709 · GCJ
Dexide, Inc.
General & Plastic Surgery · 126d
Cleared Jul 14, 1992
E-Z CLAMP#1 AND#2
K922243 · GCJ
Southwest Medical Mfg., Inc.
General & Plastic Surgery · 62d
Cleared Jul 14, 1992
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
K922296 · KTN
Ampcor, Inc.
Immunology · 60d
Cleared Jul 14, 1992
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST
K922297 · KTN
Ampcor, Inc.
Immunology · 60d
Cleared Jul 14, 1992
SUCTION/IRRIGATION Y TUBING SET
K922655 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 41d
Cleared Jul 13, 1992
IRRIGATING SYRINGE
K912437 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 406d
Cleared Jul 13, 1992
GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.
K915636 · LDQ
Associated Ent., Inc.
General & Plastic Surgery · 209d
Cleared Jul 13, 1992
VERSA-VIAL
K920177 · DQF
Bioteque America, Inc.
General Hospital · 181d
Cleared Jul 13, 1992
INDUSTRIAL STRENGTH EYEWEAR
K920701 · HQY
Grafix Marketing Group
Ophthalmic · 146d
Cleared Jul 13, 1992
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
K920795 · HQG
Optical Radiation Corp.
Ophthalmic · 143d
Cleared Jul 13, 1992
FDP PLASMA TEST KIT
K920943 · DAP
American Bioproducts Co.
Hematology · 137d
Cleared Jul 13, 1992
INSUFFLATOR, LAPAROSCOPIC
K920959 · HIF
Mectra Labs, Inc.
Obstetrics & Gynecology · 139d
Cleared Jul 13, 1992
LAPAROSCOPIC SURGICAL INSTRUMETNS
K921260 · GCJ
Jana Medical
General & Plastic Surgery · 119d
Cleared Jul 13, 1992
DIGI SPORTLENS SYSTEM
K921444 · HQY
Fitness Quest, Inc.
Ophthalmic · 110d
Cleared Jul 13, 1992
HOT OR COLD PACK (THERMIPAQ)
K921446 · IME
Thermionics Corp.
Physical Medicine · 108d
Cleared Jul 13, 1992
FLEXION DISTRATION SUPPORT
K921711 · ILZ
Altoona Medical Supply
Physical Medicine · 96d
Cleared Jul 13, 1992
CVIS INSIGHT III SYSTEM
K921750 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 91d
Cleared Jul 13, 1992
BIOLOR
K921772 · EJT
Degussa AG
Dental · 90d
Cleared Jul 13, 1992
TX ELECTRIC TOOTHBRUSH
K921773 · JEQ
Optiva Corp.
Dental · 90d