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
147265–147288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1985
URETERAL STONE DISLODGER
K851922 · FFL
Inter-Med Corp.
Gastroenterology & Urology · 92d
Cleared Aug 02, 1985
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
K852306 · JJC
Methodist Hospital of Memphis
Chemistry · 65d
Cleared Aug 02, 1985
TITANIUM PROBES
K852415 · GAD
L.A.S.E.R., Inc.
General & Plastic Surgery · 56d
Cleared Aug 02, 1985
1208 BETACORD AND 1208 BETCORD M
K852434 · JJJ
Lkb Instruments, Inc.
Toxicology · 53d
Cleared Aug 02, 1985
PRESSURE REGULATOR/Y CONNECTOR
K852649 · CAN
C.R. Bard, Inc.
Anesthesiology · 42d
Cleared Aug 02, 1985
ACA GENTAMICIN TEST PACK
K852672 · LCD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 39d
Cleared Aug 02, 1985
DC LIQUITROL LEVEL 1 & 2
K852753 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 35d
Cleared Aug 02, 1985
SOPHEIA DHEA-SO4 EIA KIT
K852847 · JKC
Diagnostic Products Corp.
Chemistry · 28d
Cleared Aug 02, 1985
CORTISOL SYSTEM BY EIA
K852939 · CGR
American Bioclinical, Inc.
Chemistry · 23d
Cleared Aug 02, 1985
BIOVATION MAX DATA MANAGEMENT SYSTEM
K853026 · JQP
Biovation, Inc.
Chemistry · 15d
Cleared Aug 02, 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
K853049 · CIX
Simmler, Inc.
Chemistry · 14d
Cleared Aug 02, 1985
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
K853050 · CIC
Simmler, Inc.
Chemistry · 14d
Cleared Aug 02, 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 10d
Cleared Aug 02, 1985
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
K853102 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 10d
Cleared Aug 01, 1985
PERMALID PAK
K842781
CooperVision, Inc.
Ophthalmic · 381d
Cleared Aug 01, 1985
PERMALID LINER PAK
K842814
CooperVision, Inc.
Ophthalmic · 379d
Cleared Aug 01, 1985
EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT
K844596
Xanmed Corp.
General & Plastic Surgery · 248d
Cleared Aug 01, 1985
ACCU-CHEK II
K851456 · CGA
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Aug 01, 1985
THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY
K851495
Thoratec Laboratories Corp.
General & Plastic Surgery · 108d
Cleared Aug 01, 1985
MDS 83 OPHTHALMIC DYE LASER SYSTEM
K852234 · HQF
Meditec, Inc.
Ophthalmic · 71d
Cleared Aug 01, 1985
INFUSION CANNULAM
K852758 · HMX
Precision Medical Instruments, Inc.
Ophthalmic · 34d
Cleared Aug 01, 1985
CARIOLINE(ELECTROCARDIOGRAPH)
K852770 · DPS
Remco Italia S.P.A.
Cardiovascular · 34d
Cleared Aug 01, 1985
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
K852840 · LJM
Modern Diagnostics, Inc.
Immunology · 27d
Cleared Aug 01, 1985
MYCOPLASMA SPP SEROLOGICAL REAGENTS
K852933 · GSB
Microbix Biosystems, Inc.
Microbiology · 23d