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
157537–157560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 01, 1983
VASCULAR-ACCESS-PORT
K830000 · LJT
Norfolk Medical Products, Inc.
General Hospital · 57d
Cleared Mar 01, 1983
INTRAMEDULLARY ROD
K830087 · HSB
The Deca Co.
Orthopedic · 49d
Cleared Mar 01, 1983
VITATHYL
K830105 · EAT
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
CIMPAT
K830109 · EMR
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
GUTTA PERCHA POINTS
K830114 · EKM
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
PAPER POINTS
K830115 · EKM
North Pacific Dental, Inc.
Dental · 49d