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
146473–146496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1985
CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N
K853623
Co-Medical, Inc.
General & Plastic Surgery · 40d
Cleared Oct 08, 1985
GAUZE SPONGE
K853742 · GDY
South Mountain Medical
General & Plastic Surgery · 32d
Cleared Oct 08, 1985
MENISCAL STITCHING KIT
K853801
Aspen Laboratories, Inc.
General & Plastic Surgery · 27d
Cleared Oct 08, 1985
MENISCAL REPAIR SYSTEM
K853829
Concept, Inc.
General & Plastic Surgery · 25d
Cleared Oct 08, 1985
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
K853883 · HQC
Medical Corp. of America
Ophthalmic · 19d
Cleared Oct 08, 1985
SUTURE REMOVAL KIT
K853910 · KDD
Scientific & Medical Care Co.
General & Plastic Surgery · 18d
Cleared Oct 07, 1985
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700
K851405 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 181d
Cleared Oct 07, 1985
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199 · LYC
Osteotech, Inc.
Dental · 140d
Cleared Oct 07, 1985
FALCON (POWERED WHEELCHAIR)
K852381 · ITI
Venturego, Inc.
Physical Medicine · 124d
Cleared Oct 07, 1985
MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE
K852860 · GEX
Coherent Medical Group
General & Plastic Surgery · 91d
Cleared Oct 07, 1985
DRILLING TEMPLATE
K853761 · GEY
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Oct 07, 1985
ISOMETRIC ACL DRILL GUIDE
K853762 · GEY
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Oct 07, 1985
TENDON STRIPPER
K853763
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Oct 07, 1985
TENDON LEADER
K853764
Orthopedic Systems, Inc.
Orthopedic · 28d
Cleared Oct 07, 1985
RAYLOR RETRACTORS
K853796 · GAD
Cedar Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Oct 07, 1985
KNEELING ATTACHMENT & CUSHIONED FACE REST SYS FOR
K853797
Cedar Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Oct 07, 1985
BONE IMPACTORS
K853798
Cedar Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Oct 07, 1985
NEUROSURGICAL HEADREST
K853799
Cedar Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Oct 07, 1985
UPPER-CHEST-SUPPORT CUSHION FOR OPERATIONS IN SITT
K853800
Cedar Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Oct 07, 1985
ATS 500 TOURNIQUET
K853802 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 26d
Cleared Oct 07, 1985
PENNINE LINK TUBING
K853839
Samco Industries, Inc.
General & Plastic Surgery · 21d
Cleared Oct 04, 1985
RHODA-LUX LENS BLANKS
K850909 · HPX
Optatint, Inc.
Ophthalmic · 213d
Cleared Oct 04, 1985
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · FGE
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 128d
Cleared Oct 04, 1985
LASERSAFE EYE SHIELDS
K852404 · HOY
Lasersafe, Inc.
Ophthalmic · 120d