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
150937–150960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1984
48 HOUR SET CHANGES
K842399 · FPB
Tri-Med, Inc.
General Hospital · 112d
Cleared Oct 09, 1984
I.V. TRANSFER SPIKE
K842678 · FPA
Lyphomed, Inc.
General Hospital · 91d
Cleared Oct 09, 1984
MED. SUPPORT STOCKING-VENOFIT LASTOFLEX
K842708 · DWL
Kundt + Co. AG
General Hospital · 89d
Cleared Oct 09, 1984
MASTER-CHEK BOWIE-DICK TYPE TEST
K843182 · JOJ
Arvey Corp.
General Hospital · 57d
Cleared Oct 05, 1984
CATAREX VITRECUTTER I/A DISPOS. CUT
K840063 · HQC
Calliope Corp.
Ophthalmic · 270d
Cleared Oct 05, 1984
CATAREX/ULTRASONICS KIT
K840181 · HQC
Calliope Corp.
Ophthalmic · 262d
Cleared Oct 05, 1984
CORNEAL LIGHT SHIELD
K840834 · HOY
Gabl, Inc.
Ophthalmic · 224d
Cleared Oct 05, 1984
AMER. SURGICAL CORP. EXTRA PLUS PAK
K841738 · HQE
American Surgical Co., Inc.
Ophthalmic · 161d
Cleared Oct 05, 1984
CANON AUTOREF R-10
K841861 · HKO
Canon USA, Inc.
Ophthalmic · 154d
Cleared Oct 05, 1984
ORTHO* RSV ANTIGEN ELISA TEST SYS
K842047 · LKT
Ortho Diagnostic Systems, Inc.
Microbiology · 137d
Cleared Oct 05, 1984
ULTRAMARK 4 ULTRASOUND SYS
K842376 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 109d
Cleared Oct 05, 1984
SAFE & SOFT PANTY SHIELDS
K842838 · HHD
Ipco Corp.
Obstetrics & Gynecology · 77d
Cleared Oct 05, 1984
MICROSCOPE MITTS SUPPORT TRAY COVER
K842859 · HJO
Chiron Vision Corp.
Ophthalmic · 74d
Cleared Oct 05, 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 74d
Cleared Oct 05, 1984
NIDEK DIGITAL KERATOMETER
K842892 · HQL
Nidek, Inc.
Ophthalmic · 74d
Cleared Oct 05, 1984
LIQUID CHROMATOGRAPHY COLUMNS
K842909 · DPM
Supelco, Inc.
Toxicology · 72d
Cleared Oct 05, 1984
SANITARY PANTY W/PADS & DESIGNED
K843015 · HHD
Hygienics Industries, Inc.
Obstetrics & Gynecology · 66d
Cleared Oct 05, 1984
CANON 60 FUNDUS CAMERA CF-60U
K843021 · HKI
Canon USA, Inc.
Ophthalmic · 65d
Cleared Oct 05, 1984
VISION TESTER
K843042 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 64d
Cleared Oct 05, 1984
RING SUPPORTED TREPHINE FOR CORNEA TRANS
K843048 · HRH
Precision Instruments, Inc.
Ophthalmic · 63d
Cleared Oct 05, 1984
TRIA LENS SET
K843095 · HPC
Optek Medico Co., Ltd.
Ophthalmic · 59d
Cleared Oct 05, 1984
ROCHE REAGENT FOR ALT
K843111 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Oct 05, 1984
FRAME SPECTACLE
K843123 · HQZ
Vision Industries Corp.
Ophthalmic · 58d
Cleared Oct 05, 1984
VISITEC FLIERINGA-LEGRAND FIXATION RING
K843195 · HMH
Visitec Co.
Ophthalmic · 52d