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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94849–94872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1997
BIOJECTOR 2000 MODEL 1B02000
K960373 · KZE
Bioject, Inc.
General Hospital · 404d
Cleared Mar 05, 1997
PS-41 6M PATIENT SIMULATOR
K963198 · DPS
Metron U.S., Inc.
Cardiovascular · 202d
Cleared Mar 05, 1997
EPILASER NORMAL MODE RUBY LASER
K963947 · GEX
Spectrum Medical Technologies, Inc.
General & Plastic Surgery · 154d
Cleared Mar 05, 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · DZE
Steri-Oss, Inc.
Dental · 134d
Cleared Mar 05, 1997
V-CATH
K964966 · FOZ
Hdc Corp.
General Hospital · 84d
Cleared Mar 05, 1997
S-SCORT (2500)
K964997 · BTA
Sscor
General & Plastic Surgery · 79d
Cleared Mar 05, 1997
LATEX EXAM GLOVES
K965155 · LYY
P.T. Irama Dinamika Latex
General Hospital · 72d
Cleared Mar 05, 1997
STERILE WATER PUMP
K970002 · EIA
Micro Motors, Inc.
Dental · 62d
Cleared Mar 05, 1997
AUROFLUID 22
K970044 · EJS
Metalor Dental USA Corp.
Dental · 58d
Cleared Mar 05, 1997
SOLARO 33
K970045 · EJS
Metalor Dental USA Corp.
Dental · 58d
Cleared Mar 05, 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 57d
Cleared Mar 05, 1997
BIOPSY TRAY
K970152 · FRG
Medcare Medical Group, Inc.
General Hospital · 48d
Cleared Mar 04, 1997
EZTEST-GAS
K930683 · FRC
Sgm Biomedical, Inc.
General Hospital · 1483d
Cleared Mar 04, 1997
AUTOSTATTMII ANTI-DSDNA
K952567 · LRM
Cogent Diagnotics , Ltd.
Immunology · 638d
Cleared Mar 04, 1997
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
K954676 · KOC
Nissho Corp.
Gastroenterology & Urology · 511d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661 · DXG
Abbott Laboratories
Cardiovascular · 308d
Cleared Mar 04, 1997
STRYKER ENCORE STERILIZER
K962755 · FLE
Stryker Corp.
General Hospital · 231d
Cleared Mar 04, 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257 · LJS
Arrow Intl., Inc.
General Hospital · 197d
Cleared Mar 04, 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · DZE
Dentsply Intl.
Dental · 146d
Cleared Mar 04, 1997
FLEXILOG 3000
K964589 · KLA
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 109d
Cleared Mar 04, 1997
MD-1835
K964806 · IXL
Fischer Imaging Corp.
Radiology · 95d
Cleared Mar 04, 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855 · HOZ
Shippert Medical Technologies Corp.
Ophthalmic · 90d
Cleared Mar 04, 1997
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY...
K964879 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 89d
Cleared Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 78d