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
84433–84456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1999
HEMASEAL & CIDE
K990779 · LBH
Advantage Dental Products, Inc.
Dental · 253d
Cleared Nov 17, 1999
PHACOLASE ER: YAG LASER
K991993 · GEX
Aesculap-Meditec GmbH
General & Plastic Surgery · 156d
Cleared Nov 17, 1999
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
K992678 · LZA
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 99d
Cleared Nov 17, 1999
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · LBH
Dentsply Intl.
Dental · 86d
Cleared Nov 17, 1999
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER...
K992824 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 86d
Cleared Nov 17, 1999
NON-STICK BIPOLAR FORCEPS
K992931 · GEI
Silverglide Surgical Technologies
General & Plastic Surgery · 78d
Cleared Nov 17, 1999
MODIFIED BLOOD RECIPIENT SET
K993120 · BRZ
Baxter Healthcare Corp
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
K993133 · LZA
Seal Polymer Industries Bhd.
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)
K993134 · LZA
Seal Polymer Industries Bhd.
General Hospital · 58d
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