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
168601–168624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1979
SYSTEC 280 INTEGRATED SUCTION SYSTEM
K791349 · BTA
Stryker Corp.
General & Plastic Surgery · 53d
Cleared Sep 07, 1979
THE MTD VARA SET CASETTE HOLDER
K791374 · KPR
Mtd, Inc.
Radiology · 45d
Cleared Sep 07, 1979
CATHETERIZATION TRAYS FOLEY AND URETHRAL
K791427 · KOD
Intermed, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 07, 1979
VACUTOME SUCTION UNIT
K791494
Concept, Inc.
General & Plastic Surgery · 36d
Cleared Sep 07, 1979
AUTOMATIC POSITIVE BEAM COLLIMATOR
K791504 · KPW
Dial-X Instruments, Inc.
Radiology · 32d
Cleared Sep 07, 1979
DISPOSABLE MEDICATION NEBULIZER
K791536 · CAF
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
DISPOSABLE MOUTHPIECE
K791537 · BYP
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
DISPOSABLE AEROSOL T
K791538 · BZA
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
DISPOSABLE 22MM ADAPTOR
K791539 · BZA
Hospitak, Inc.
Anesthesiology · 28d
Cleared Sep 07, 1979
GILLETTE CORDLESS WHIRLPOOL
K791603 · ILJ
The Gillette Company
Physical Medicine · 24d
Cleared Sep 07, 1979
REUSABLE MOIST HEAT PACK
K791653 · IMA
Tru-Eze Mfg. Co., Inc.
Physical Medicine · 24d
Cleared Sep 07, 1979
MEDTRONIC MODELS 69914/699OU
K791667 · DTB
Medtronic Vascular
Cardiovascular · 10d
Cleared Sep 07, 1979
LITHICRON II 0403 IMPLANTABLE PACEMAKER
K791678 · DXY
Medcor, Inc.
Cardiovascular · 10d
Cleared Sep 04, 1979
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702 · DEW
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
ANTISERA TO HUMAN FRAGMENT
K790711 · DFK
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
ANTISERUM TO HUMAN HEMOPEXIN
K790713 · CZX
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
RP-610 PARALLEL PLATE DIALYZER
K790827 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 137d
Cleared Sep 04, 1979
TONGUE SCRAPER
K790895 · LCN
Peter G. Finamore, Sr.
Dental · 120d
Cleared Sep 04, 1979
MODEL 114 TREONIC H150 HAEMOHEATER
K790936 · KZL
Vickers America Medical Corp.
Hematology · 109d
Cleared Sep 04, 1979
VITREOUS SUCTION/CUTTER
K791000 · HKP
Concept, Inc.
Ophthalmic · 98d
Cleared Sep 04, 1979
DENTAL XERORADIOGRAPHY
K791014 · EAP
Xerox Medical Systems
Radiology · 95d
Cleared Sep 04, 1979
FETASONDE FETAL ACTIVITY MONITOR
K791035 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE UTERINE WORK MONITOR
K791036 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE LABOR STATUS DISPLAY
K791037 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d