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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83929–83952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1999
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
K993251 · LIG
Diagnostic Products Corp.
Chemistry · 50d
Cleared Nov 17, 1999
NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A...
K993326 · LYY
Seal Polymer Industries Bhd.
General Hospital · 44d
Cleared Nov 17, 1999
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13,...
K993588 · FGE
Guidant Corp.
Gastroenterology & Urology · 26d
Cleared Nov 17, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669 · DFC
DiaSorin, Inc.
Chemistry · 16d
Cleared Nov 16, 1999
BONE BULLET SUTURE ANCHOR
K991024 · HWC
Linvatec Corp.
Orthopedic · 232d
Cleared Nov 16, 1999
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018...
K991059 · DQY
Spectranetics Corp.
Cardiovascular · 231d
Cleared Nov 16, 1999
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
K992287 · HSX
Howmedica Osteonics Corp.
Orthopedic · 132d
Cleared Nov 16, 1999
UNI-GRAFT K DV PATCH
K992776 · DXZ
Atrium Medical Corp.
Cardiovascular · 90d
Cleared Nov 16, 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Nov 16, 1999
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
K992793 · FIN
Better Water, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 16, 1999
RICROKERATOME BLADE
K992978 · HNO
Surgistar, Inc.
Ophthalmic · 74d
Cleared Nov 16, 1999
ETEST FOR QUINUPRISTIN/DALFOPRISTIN
K992993 · LTX
Ab Biodisk
Microbiology · 70d
Cleared Nov 16, 1999
SILHOUETTE SPINAL FIXATION SYSTEM
K993067 · KWP
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Nov 16, 1999
SABRE
K993177 · GWJ
Sle Limited
Neurology · 85d
Cleared Nov 16, 1999
E Z CHAIR
K993298 · IOR
Premier Designs
Physical Medicine · 46d
Cleared Nov 16, 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · HRS
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 16, 1999
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 16, 1999
SPECTRUM LIBRE WHEELCHAIR
K993640 · IOR
Freedom Designs, Inc.
Physical Medicine · 19d
Cleared Nov 16, 1999
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND...
K993647 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 18d
Cleared Nov 16, 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · HSB
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Nov 16, 1999
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
K993715 · JJT
Seracare Technology
Immunology · 13d
Cleared Nov 15, 1999
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC...
K992838 · KLE
Biomat Sciences, Inc.
Dental · 84d
Cleared Nov 15, 1999
MINIMED COM-STATION, HARDWARE-7301
K993012 · LZG
Medtronic Minimed
General Hospital · 68d
Cleared Nov 15, 1999
P10 SPECIAL
K993344 · EJH
North American Alloys, Inc.
Dental · 41d