Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
158377–158400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1983
UNICIDE
K830106 · LFE
North Pacific Dental, Inc.
Dental · 55d
Cleared Mar 07, 1983
MINIATURE ION SELECTIVE ELECTRODES
K830130 · JSG
Ionetics, Inc.
Chemistry · 55d
Cleared Mar 07, 1983
BETA-CAP D ADAPTER
K830208 · FKX
Quinton, Inc.
Gastroenterology & Urology · 45d
Cleared Mar 07, 1983
FECAL OCCULT SLIDE TEST KIT
K830223 · KHE
Cambridge Chemical Products, Inc.
Chemistry · 42d
Cleared Mar 07, 1983
OTOLOGICAL VENTILATION TUBES-VARIOUS
K830228 · ETD
Micromedics, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 07, 1983
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · JXA
Granite Diagnostics, Inc.
Microbiology · 41d
Cleared Mar 07, 1983
800 BLUE
K830303 · ESD
Electone, Inc.
Ear, Nose, Throat · 38d
Cleared Mar 07, 1983
PARAMAX ANALYTICAL SYS
K830318 · JJE
American Dade
Chemistry · 35d
Cleared Mar 07, 1983
LEGIONELLA SELECTIVE SUPPLEMENTS
K830384 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 31d
Cleared Mar 07, 1983
HEARING AID, #UE7-D
K830402 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 07, 1983
SYRINGE DRIVER MS-16
K830423 · FRN
Intermedics, Inc.
General Hospital · 27d
Cleared Mar 07, 1983
BEHIND THE EAR HEARING AID OMNI #OS
K830459 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 20d
Cleared Mar 07, 1983
ELDER PSORALITE, SERIES 43000
K837105
Elder Pharmaceuticals, Inc.
Radiology · 56d
Cleared Mar 04, 1983
UNKNOWN
K828326
Lasertek OY
Radiology · 38d
Cleared Mar 04, 1983
SYSTEM 900 TWO ROOM REMOTE FIBERS
K837125
Coherent Radiation Laboratories
Radiology · 28d
Cleared Mar 04, 1983
MODELS EUROSUN 2400 AND 800
K837139
Eurosun Scaenda Sol
Radiology · 52d
Cleared Mar 03, 1983
ULTRASCAN DIGITAL A/SYSTEM III
K828328
Cooper Lasersonics, Inc.
Radiology · 78d
Cleared Mar 02, 1983
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
K830284 · KDI
Gambro, Inc.
Gastroenterology & Urology · 34d
Cleared Mar 02, 1983
BUDDE-HALO RETRACTOR
K830332 · GZT
Ohio Medical Instrument Co., Inc.
Neurology · 29d
Cleared Mar 01, 1983
MR 600 MICROPLATE READER
K823512 · JJQ
Laboratory and Medical Products Group
Chemistry · 92d
Cleared Mar 01, 1983
ABBOTT LABORATORIES STREP A EIA
K823569 · GTZ
Abbott Laboratories
Chemistry · 88d
Cleared Mar 01, 1983
PORT-LOCK
K823845 · FPA
Norfolk Medical Products, Inc.
General Hospital · 70d
Cleared Mar 01, 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · JXA
Marion Laboratories, Inc.
Microbiology · 70d
Cleared Mar 01, 1983
PROFILE 750 BLOOD CELL COUNTER
K823886 · GKL
Mallinckrodt Critical Care
Hematology · 64d