FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81961–81984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2000
JILCO TRACTION-FLEXION CHAIR
K001361 · ITH
Jilco Enterprises
Physical Medicine · 82d
Cleared Jul 19, 2000
O-LAS OPHTHALMIC PHOTODISRUPTOR
K001511 · GEX
A.R.C. Laser AG
General & Plastic Surgery · 65d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · GWG
Karl Storz Endoscopy
Neurology · 54d
Cleared Jul 19, 2000
REDON SET
K001716 · JCX
Pfm Produkte Fur Die Medizin AG
General & Plastic Surgery · 44d
Cleared Jul 19, 2000
COOL-TEC ELECTRODES
K001723 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 43d
Cleared Jul 19, 2000
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
K001746 · GEX
Coherent Star
General & Plastic Surgery · 41d
Cleared Jul 19, 2000
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001751 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001752 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001754 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 19, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
K001936 · GEI
Arthrocare Corp.
General & Plastic Surgery · 23d
Cleared Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared Jul 19, 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · IPF
Control Solutions, Inc.
Physical Medicine · 281d
Cleared Jul 19, 2000
SPINAL PAD
K993684 · ILY
Bioscan, Inc.
Physical Medicine · 261d
Cleared Jul 19, 2000
NANMA VACUUM PUMP
K993909 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Jul 19, 2000
GEM KNEE SYSTEM
K994214 · JWH
Kinamed, Inc.
Orthopedic · 218d
Cleared Jul 18, 2000
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
K001298 · IOR
Roll-Ability (Pty) , Ltd.
Physical Medicine · 85d
Cleared Jul 18, 2000
DASH 3000/4000 PATIENT MONITOR
K001359 · DSI
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 71d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612 · JWY
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 18, 2000
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
K001964 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 21d
Cleared Jul 18, 2000
CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
K992182 · GCJ
Ca Guard, Ltd.
General & Plastic Surgery · 386d