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
106681–106704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1994
STRYKER 2S SPINAL SYSTEM
K930009 · KWP
Stryker Corp.
Orthopedic · 605d
Cleared Sep 01, 1994
PRECISION OSTEOLOCK ACETABULAR COMPONENT
K930275 · JDI
Howmedica Corp.
Orthopedic · 590d
Cleared Sep 01, 1994
STAPLE, FIXATION BONE
K931155 · HWC
Roseburg SA
Orthopedic · 541d
Cleared Sep 01, 1994
TECHMEDICA CONTINUUM HIP WITH HA COATING
K932017 · MEH
Techmedica, Inc.
Orthopedic · 493d
Cleared Sep 01, 1994
TOTAL KNEE KIT
K932918 · HWE
Biodynamic Technologies, Inc.
Orthopedic · 443d
Cleared Sep 01, 1994
ORTHOLOC ADVANTIM
K933290 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 422d
Cleared Sep 01, 1994
INDEX SPO2 SIMULATOR
K933519 · DQA
Bio-Tek Instruments, Inc.
Anesthesiology · 408d
Cleared Sep 01, 1994
ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE
K934620 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 339d
Cleared Sep 01, 1994
PROPAQ ECG TELEMETRY OPTION
K934711 · DRG
Protocol Systems, Inc.
Cardiovascular · 335d
Cleared Sep 01, 1994
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS
K934811 · GEX
Candela Laser Corp.
General & Plastic Surgery · 329d
Cleared Sep 01, 1994
SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES
K941710 · DQX
Scimed Peripheral Interventions
Cardiovascular · 148d
Cleared Sep 01, 1994
SLASE 210 PLUS HOLMIUM LASER SYSTEM
K942542 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 97d
Cleared Sep 01, 1994
CLINICAL BLOOD GAS MIXTURE
K942866 · BXK
Nordan Smith Welding Supplies
Anesthesiology · 76d
Cleared Sep 01, 1994
ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE
K943542 · GEI
Conmedcorp
General & Plastic Surgery · 41d
Cleared Sep 01, 1994
O-R-EZ TIP CLEANER
K943991 · GEI
O-R-Ez, Inc.
General & Plastic Surgery · 16d
Cleared Aug 31, 1994
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 559d
Cleared Aug 31, 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 107d
Cleared Aug 31, 1994
OPTICON(TM) CONNECTOR ADAPTER II
K942759 · GEX
Xintec Corporation
General & Plastic Surgery · 79d
Cleared Aug 31, 1994
JEMSDAL MASK
K942907 · BYG
Respan Products, Inc.
Anesthesiology · 71d
Cleared Aug 31, 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939 · DQO
Cordis Corp.
Cardiovascular · 70d
Cleared Aug 31, 1994
AG-839PA CO2 MODULE AND ACCESSORIES
K944027 · BXO
Nihon Kohden America, Inc.
Anesthesiology · 14d
Cleared Aug 30, 1994
SEMEN ANALYSIS KIT
K915229 · POV
Humagen Fertility Diagnostics, Inc.
Hematology · 1014d
Cleared Aug 30, 1994
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
K925560 · HGI
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 665d
Cleared Aug 30, 1994
SENTRY AQUEOUS GEL ECG ELECTRODES
K934000 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 378d