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
154465–154488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1984
ELECTROCARDIOGRAPH MACHINES, W/ANALYZ
K832092
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Jan 03, 1984
DRUMTO STAPES PROSTHESIS
K832540 · ETB
Humboldt Products
Ear, Nose, Throat · 158d
Cleared Jan 03, 1984
ULTRAFILTRATION CONTROLLER
K832547 · KDI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 155d
Cleared Jan 03, 1984
RAAF CATHETER REPAIR KIT
K832580 · LJS
Quinton, Inc.
General Hospital · 154d
Cleared Jan 03, 1984
NON-INVASIVE CLINICAL VASCULAR LAB
K832679 · DQC
Life Sciences Manufacturing, Inc.
Cardiovascular · 147d
Cleared Jan 03, 1984
REPAIR KITS FOR RIGHT ATRIAL CATH
K832774 · LJS
Quinton, Inc.
General Hospital · 140d
Cleared Jan 03, 1984
SHUFFIELD TECH ENEMA TIP
K832960 · FCE
Shuffield Tech Co.
Gastroenterology & Urology · 126d
Cleared Jan 03, 1984
CEPHALOMETER & FIXATOR
K833006 · EAG
Modern Systems, Inc.
Radiology · 119d
Cleared Jan 03, 1984
O.B. TAMPONS
K833179 · HEB
Personal Products Co.
Obstetrics & Gynecology · 106d
Cleared Jan 03, 1984
INTERIM TEMP. CROWN & BRIDGE RESIN
K833261 · EBG
Coe Laboratories, Inc.
Dental · 102d
Cleared Jan 03, 1984
SATIN CAST ECONOCAST
K833287 · EIS
Genesis Industries, Inc.
Dental · 103d
Cleared Jan 03, 1984
C & B 40 PENTRO C & B40
K833290 · EIS
Genesis Industries, Inc.
Dental · 103d
Cleared Jan 03, 1984
NORMAL GOAT SERUM
K833318 · DHX
Biosan Laboratories, Inc.
Immunology · 99d
Cleared Jan 03, 1984
ARMBOARD
K833559 · KPR
Mtd, Inc.
Radiology · 90d
Cleared Jan 03, 1984
HC PLUS
K833563 · JPK
Coulter Electronics, Inc.
Hematology · 83d
Cleared Jan 03, 1984
ANTRUM & ATTIC MIRROR
K833601 · KAI
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
ROLLER KNIFE-TRANSVERSE -SAGITTAL
K833602 · JYO
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
SCISSORS SHEA BELLUCC
K833603 · JZB
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
ADJUSTABLE FORK RETRACTOR
K833604 · KAL
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
CUPPED FORCEPS
K833605 · KAE
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
IMPLANT MEASURING GAUGE
K833606 · JYJ
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
MCGEE FORCEPS
K833607 · KAE
Microtek Medical, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1984
BOS-CM40,50 HOLDER & RESERVOIR BAG
K833670 · DTZ
American Bentley
Cardiovascular · 77d
Cleared Jan 03, 1984
GLYCOGLOBIN KIT
K833805 · LCP
Endocrine Sciences Products
Hematology · 63d