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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
99913–99936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1995
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
K954782 · HJO
Kowa Optimed, Inc.
Ophthalmic · 38d
Cleared Nov 22, 1995
XCHF-33 CHOLEDOCHOFIBERSCOPE
K944473 · FBN
Olympus America, Inc.
Gastroenterology & Urology · 439d
Cleared Nov 22, 1995
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
K946175 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 338d
Cleared Nov 22, 1995
WALLACH DIGITAL IMAGING SYSTEM
K950630 · LMB
Wallach Surgical Devices, Inc.
Radiology · 282d
Cleared Nov 22, 1995
BODYSTAY
K951097 · DSB
Bodystat , Ltd.
Cardiovascular · 259d
Cleared Nov 22, 1995
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K951139 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 254d
Cleared Nov 22, 1995
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
K952447 · FPO
Hill-Rom, Inc.
General Hospital · 181d
Cleared Nov 22, 1995
PROBE PERSONAL LUBRICANT - CLASSIC
K952464 · HIS
Davryan Laboratories, Inc.
Obstetrics & Gynecology · 180d
Cleared Nov 22, 1995
PROBE PERSONAL LUBRICANT - SILKY LIGHT
K952465 · HIS
Davryan Laboratories, Inc.
Obstetrics & Gynecology · 180d
Cleared Nov 22, 1995
INSPECT/PROSPECT
K952564 · KPS
Adac Laboratories
Radiology · 173d
Cleared Nov 22, 1995
DURASIL
K952612 · MDA
The S. F. Group, Inc.
General & Plastic Surgery · 168d
Cleared Nov 22, 1995
BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
K952719 · KHO
Biocircuits Corp.
Chemistry · 160d
Cleared Nov 22, 1995
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
K952913 · JAQ
Varian Assoc., Inc.
Radiology · 149d
Cleared Nov 22, 1995
CASPER
K953227 · IXI
Northwest Medical Physics Center
Radiology · 140d
Cleared Nov 22, 1995
CP 100/30
K953292 · IZL
Micro-Focus Imaging., Inc.
Radiology · 132d
Cleared Nov 22, 1995
RESPOSABLE RESUSCITATOR
K953617 · BTM
Medical Marketing Concepts
Anesthesiology · 111d
Cleared Nov 22, 1995
AXSYM TRICYCLIC ANTIDEPRESSANTS
K953761 · LFH
Abbott Laboratories
Toxicology · 103d
Cleared Nov 22, 1995
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
K953768 · DRF
Cordis Webster, Inc.
Cardiovascular · 100d
Cleared Nov 22, 1995
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
K953771 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 100d
Cleared Nov 22, 1995
VARICAM
K953801 · KPS
Elscint, Inc.
Radiology · 103d
Cleared Nov 22, 1995
ARISTO MEDICAL MODEL 2101 PATIENT MONITOR
K953817 · DQA
Aristo Medical Products, Inc.
Anesthesiology · 100d
Cleared Nov 22, 1995
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · NFB
Invacare Corp.
Anesthesiology · 98d
Cleared Nov 22, 1995
PARALLEL
K954007 · KGX
Johnson & Johnson Consumer Products,...
General & Plastic Surgery · 89d
Cleared Nov 22, 1995
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
K954023 · MEH
Osteonics Corp.
Orthopedic · 86d