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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36793–36816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2014
3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
K140392 · FRC
3M Company
General Hospital · 180d
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · MBI
Arthrex, Inc.
Orthopedic · 168d
Cleared Aug 13, 2014
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST...
K140782 · NRB
Celleration, Inc.
General & Plastic Surgery · 135d
Cleared Aug 13, 2014
FINGERTIP PULSE OXIMETER
K141128 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 104d
Cleared Aug 13, 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517 · HRS
Zimmer, Inc.
Orthopedic · 65d
Cleared Aug 13, 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734 · HRS
Zimmer, Inc.
Orthopedic · 47d
Cleared Aug 13, 2014
FIBERGRAFT BG MORSELS
K141956 · MQV
Prosidyan, Inc.
Orthopedic · 26d
Cleared Aug 12, 2014
BAHADIR STERILIZATION TRAYS
K131407 · KCT
Bahadir USA Corp.
General Hospital · 454d
Cleared Aug 12, 2014
ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS
K133255 · DZE
Dentalpoint AG
Dental · 293d
Cleared Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
K133358 · HQF
Nidek Co., Ltd.
Ophthalmic · 285d
Cleared Aug 12, 2014
CATARHEX 3
K133562 · HQC
Oertli Instrumente AG
Ophthalmic · 265d
Cleared Aug 12, 2014
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
K134014 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 225d
Cleared Aug 12, 2014
POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
K140988 · KGO
Hebei Hongsen Plastics Technology Co,...
General Hospital · 117d
Cleared Aug 12, 2014
DA VINCI FIREFLY IMAGING SYSTEM
K141077 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 109d
Cleared Aug 12, 2014
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD
K141225 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 92d
Cleared Aug 12, 2014
Elecsys Estradiol III CalSet
K142021 · JIT
Roche Diagnostics
Chemistry · 18d
Cleared Aug 12, 2014
LLD EZ
K142116 · DRB
Spectranetics, Inc.
Cardiovascular · 8d
Cleared Aug 11, 2014
CUTERA PICOSECOND LASER SYSTEM
K133945 · GEX
Cutera, Inc.
General & Plastic Surgery · 231d
Cleared Aug 11, 2014
NEUROBLATE SYSTEM
K141983 · GEX
Monteris Medical Corp.
General & Plastic Surgery · 21d
Cleared Aug 08, 2014
SAVINA 300 SAVINA 300, COUNTRY VARIANTS
K121886 · CBK
Draeger Medical GmbH
Anesthesiology · 771d
Cleared Aug 08, 2014
BLUE NITRILE POWDER FREE EXAM GLOVES
K133325 · LZA
Shandong Xinshi Medical Products Co.,...
General Hospital · 283d
Cleared Aug 08, 2014
EMBRYOVIEWER SOFTWARE
K133712 · MQG
Unisense Fertilitech A/S
Obstetrics & Gynecology · 246d
Cleared Aug 08, 2014
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K133751 · JIT
Diamond Diagnostics, Inc.
Chemistry · 242d
Cleared Aug 08, 2014
SENSILIGHT/ SENSILIGHT PLUS
K140381 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 175d