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
148777–148800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1985
ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS
K843708 · LLZ
Adac Laboratories
Radiology · 207d
Cleared Apr 16, 1985
ND1100 BONE DENSITY SCANNER
K844766 · KGI
Nuclear Data, Inc.
Radiology · 130d
Cleared Apr 16, 1985
HEAD-SPINE STABILIZER HSS-1
K844926 · JAK
Imaging Accessories, Inc.
Radiology · 118d
Cleared Apr 16, 1985
BIOLOGICAL TELEMETRY SYSTEM
K850087
Chattanooga Group, Inc.
Physical Medicine · 95d
Cleared Apr 16, 1985
ELEKIBAN MAGNETO-THERAPEUTIC DEVICE
K850172
Mns, Ltd.
Physical Medicine · 90d
Cleared Apr 16, 1985
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173 · IZH
Ausonics Pty , Ltd.
Radiology · 90d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050
K850315 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050
K850316 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050
K850317 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 81d
Cleared Apr 16, 1985
ULTRAFIL-LT (GUTTA PERCHA)
K850863 · EKM
The Hygenic Corp.
Dental · 46d
Cleared Apr 16, 1985
TRIAD C & B MATERIAL
K850911 · EBF
Dentsply Intl.
Dental · 42d
Cleared Apr 16, 1985
WAX BITE IMPRESSION WAFER
K850915 · EGD
Toothprints, Inc.
Dental · 42d
Cleared Apr 16, 1985
BOVO MOISTURE GUARD
K850988 · KHR
E.H. Medical Co.
Dental · 36d
Cleared Apr 16, 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · JOQ
Medtronic Vascular
Cardiovascular · 29d
Cleared Apr 15, 1985
HENNING MENISCAL SUTURE KIT
K843942 · LXH
Stryker Corp.
Orthopedic · 188d
Cleared Apr 15, 1985
PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE
K850046 · HPX
Professional Supplies, Inc.
Ophthalmic · 98d
Cleared Apr 15, 1985
WOUND DRESSING MODEL ZB-6
K850076 · NAD
Thermedics, Inc.
General & Plastic Surgery · 96d
Cleared Apr 15, 1985
KCP PAK CONVENIENCE PACK
K850148 · HQC
CooperVision, Inc.
Ophthalmic · 91d
Cleared Apr 15, 1985
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
K850149 · HQC
CooperVision, Inc.
Ophthalmic · 91d
Cleared Apr 15, 1985
SPARCO SCOPE GUARD
K850268 · FEB
Sparco, Inc.
General Hospital · 82d
Cleared Apr 15, 1985
KCP PAK #2 CONVENIENCE PACK MODIFICATION
K850275 · HQC
CooperVision, Inc.
Ophthalmic · 82d
Cleared Apr 15, 1985
PLUS 1
K850478 · IYO
Dymax Corp
Radiology · 63d
Cleared Apr 15, 1985
ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK
K850532 · HQC
Atlantic Optical Systems, Inc.
Ophthalmic · 63d
Cleared Apr 15, 1985
AMNIGLOVE & AMNICOT
K850758 · HGE
Go Medical Industries Pty. , Ltd.
Obstetrics & Gynecology · 49d