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
154345–154368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1984
LH RIA
K833854 · CEP
Syncor Intl. Corp.
Chemistry · 70d
Cleared Jan 13, 1984
AMYLASE REAGENT SET-MODIFIED CARAWAY
K833864 · CJA
Sterling Biochemical, Inc.
Chemistry · 67d
Cleared Jan 13, 1984
VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
K833878 · KXT
Vxr, Inc.
Toxicology · 66d
Cleared Jan 13, 1984
ACETABULAR SCREW RING
K833881 · JDI
Mecron Medical Products, Inc.
Orthopedic · 65d
Cleared Jan 13, 1984
TRI-LEVEL BILIRUBIN CONTROLS
K833898 · JJX
Sandare Chemical Co., Inc.
Chemistry · 60d
Cleared Jan 13, 1984
BAC-T-SCREEN
K833917 · JTA
Marion Laboratories, Inc.
Chemistry · 60d
Cleared Jan 13, 1984
UREA NITROGEN-UV
K833931 · CDQ
Seragen Diagnostics, Inc.
Chemistry · 60d
Cleared Jan 13, 1984
TOTAL PROTEIN REAGENT CS-724
K833950 · CEK
Fisher Scientific Co., LLC
Chemistry · 59d
Cleared Jan 13, 1984
PEPTIC DIGEST AGAR
K834020 · JSJ
Micro Media Laboratories
Microbiology · 53d
Cleared Jan 13, 1984
TITERTEK ENTEROBAC*
K834090 · JSS
Flow Laboratories, Inc.
Microbiology · 46d
Cleared Jan 13, 1984
TABLE, MODELS 610,611 & 612
K834103 · INQ
Tri W-G, Inc.
Physical Medicine · 45d
Cleared Jan 13, 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · DXT
Cordis Corp.
Cardiovascular · 45d
Cleared Jan 13, 1984
CHIROPRACTIC ACTIVATOR OR PORT. CHIRO
K834137
Rhode Island Chiropractic Pain Clinic
Physical Medicine · 44d
Cleared Jan 13, 1984
CONCHATHERM LHF HUMIDIFIER HEATER
K834151 · BTT
Respiratory Care, Inc.
Anesthesiology · 43d
Cleared Jan 13, 1984
REVERSE-FLOW SYSTEM
K834264 · JTA
Applied Polytechnology, Inc.
Microbiology · 36d
Cleared Jan 13, 1984
ELECTRONIC CELL ENERGIZER
K834293 · LBG
Electronic Energy, Inc.
Physical Medicine · 36d
Cleared Jan 13, 1984
CAMPY 3
K834313 · JSJ
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
CAMPY 5
K834314 · JSJ
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
STERILE SALINE 0.85%
K834315 · JSM
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
WATER W/TWEEN 80
K834316 · JSM
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
SELENITE BROTH
K834317 · JSJ
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
BRUCELLA W/H & K
K834318 · JSJ
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
BHI AGAR
K834319 · JSG
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
TCBS
K834320 · JSI
Hardy Media
Microbiology · 35d