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
139801–139824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1987
STD-228 SPECTRAL TREND DISPLAY
K871480 · GWS
Grass-Telefactor Product Group
Neurology · 17d
Cleared Apr 30, 1987
ALGINATE WOOL FIBER
K870383 · KHR
Adri
Dental · 90d
Cleared Apr 30, 1987
ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE
K871007 · FMF
Habley Medical Technology Corp.
General Hospital · 48d
Cleared Apr 30, 1987
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
K871154 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 30, 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 34d
Cleared Apr 30, 1987
AM CATH ESWL STENT
K871291 · FAD
Inter-Med Corp.
Gastroenterology & Urology · 30d
Cleared Apr 30, 1987
MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER
K871464 · EFN
Medgroup Enterprises, Inc.
Dental · 16d
Cleared Apr 30, 1987
SWIVEL CONNECTORS #014452/#014453/#014459-120
K871540 · FPK
Clinical Connections, Inc.
General Hospital · 23d
Cleared Apr 30, 1987
MERIVAARA EMERGENCY PATIENT TROLLEY #436
K871556 · FPO
Global Medical Prods, Inc.
General Hospital · 8d
Cleared Apr 29, 1987
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
K864128 · LJP
Diagnostic Technology, Inc.
Microbiology · 190d
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · LJC
Abbott Laboratories
Microbiology · 140d
Cleared Apr 29, 1987
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
K870175 · JTN
Difco Laboratories, Inc.
Microbiology · 104d
Cleared Apr 29, 1987
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG
K870201 · JTN
Difco Laboratories, Inc.
Microbiology · 99d
Cleared Apr 29, 1987
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
K870518 · FMF
Surgitek
General Hospital · 83d
Cleared Apr 29, 1987
CALCIUM TEST
K870629 · CIC
Sclavo, Inc.
Chemistry · 75d
Cleared Apr 29, 1987
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
K870946 · LJP
Serono Diagnostics, Inc.
Microbiology · 51d
Cleared Apr 29, 1987
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
K870958 · CEF
Helena Laboratories
Chemistry · 50d
Cleared Apr 29, 1987
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
K871144 · DHN
Vitrotec Laboratories, Inc.
Immunology · 37d
Cleared Apr 29, 1987
10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE
K871360 · MPB
Quinton, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 29, 1987
CONTROLCHEK(TM)
K871445 · JTO
Petra Biomedical Products, Inc.
Microbiology · 16d
Cleared Apr 29, 1987
ULTRA-VIOLET GLUCOSE REAGENT KIT
K871456 · CFR
Biochemical Trade, Inc.
Chemistry · 16d
Cleared Apr 29, 1987
NEUTRAL RED
K871477 · KFE
Sigma Chemical Co.
Pathology · 15d
Cleared Apr 29, 1987
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES
K871483 · KIZ
Isratech Marketing Corp.
Pathology · 14d
Cleared Apr 29, 1987
TITAN GEL IMMUNOFIX CONTROLS
K871498 · DFT
Helena Laboratories
Immunology · 13d