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
156361–156384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1983
ARM SLINGS
K831549 · ILI
Fred Sammons, Inc.
Physical Medicine · 49d
Cleared Jun 30, 1983
CERTAIN *DENTAL RESTORATIVE
K831559 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 45d
Cleared Jun 30, 1983
SONTEK INFUSION CATHETER
K831562 · DQO
Sontek Corp.
Cardiovascular · 45d
Cleared Jun 30, 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 45d
Cleared Jun 30, 1983
RELIANCE TEMPO OPHTH. INSTR STAND
K831568 · HHF
F. & F. Koenigkramer
Obstetrics & Gynecology · 45d
Cleared Jun 30, 1983
REAGENT CUPS
K831569 · JJG
American Scientific Products
Chemistry · 45d
Cleared Jun 30, 1983
ROTOR
K831571 · JJG
American Scientific Products
Chemistry · 45d
Cleared Jun 30, 1983
NU-CAP CALCIUM HYDROX. PULP CAPPING
K831575 · EJK
Coe Laboratories, Inc.
Dental · 45d
Cleared Jun 30, 1983
AORTIC ROOT CANNULA W/INTEGRAL PRESS
K831591 · DWF
Dlp, Inc.
Cardiovascular · 44d
Cleared Jun 30, 1983
SERO/TEX RED CELL RF TEST
K831597 · DHR
Texas Immunology, Inc.
Immunology · 44d
Cleared Jun 30, 1983
HEMATOLOGY PAK
K831605 · IAF
Mercedes Scientific Co., Inc.
Hematology · 43d
Cleared Jun 30, 1983
ACCU-FLUSH
K831637 · KRA
Accu-Line
Cardiovascular · 38d
Cleared Jun 30, 1983
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · EBI
Dentsply Intl.
Dental · 38d
Cleared Jun 30, 1983
ARTHROSCOPY KNIVES/PROBES/BENDING TOOL
K831656 · HRX
Richards Manufacturer Co.
Orthopedic · 38d
Cleared Jun 30, 1983
OXY-SWAB
K831673 · JTO
Austin Biological Laboratories
Microbiology · 38d
Cleared Jun 30, 1983
RIM-CAMP TEST
K831674 · JTO
Austin Biological Laboratories
Microbiology · 38d
Cleared Jun 30, 1983
TWIST LOCK DRILL 1120
K831675 · GET
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 38d
Cleared Jun 30, 1983
PRIVATE LABEL DEODORANT MAXISHIELD
K831691 · HHL
Int'L Consumer Disposables
Obstetrics & Gynecology · 37d
Cleared Jun 30, 1983
RARE-EARTH INTRA-OCULAR MAGNET
K831702 · HPN
Miami Eye Technology, Inc.
Ophthalmic · 36d
Cleared Jun 30, 1983
AUDIOSCOPE #23000 W/71123 CHARGING STAND
K831709 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 30, 1983
CORONARY INFUSION CATHETER
K831717 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Jun 30, 1983
PLASMA THERAPY TUBESET-E100 SERIES
K831747 · FJK
Parker Hannifin Corp.
Hematology · 29d
Cleared Jun 30, 1983
NEURO EASE
K831785 · GXY
Andover Medical, Inc.
Neurology · 27d
Cleared Jun 30, 1983
TRULIFE SILICONE BREAST FORM
K831831 · GBI
Medeering, Ltd.
General & Plastic Surgery · 23d