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
36193–36216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2014
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K142084 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 89d
Cleared Oct 28, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
K142170 · LON
Becton, Dickinson and Company
Microbiology · 82d
Cleared Oct 28, 2014
Well Lead PVC Urethral Catheter
K142563 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 47d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Covidien, LLC
Cardiovascular · 40d
Cleared Oct 28, 2014
E-CUBE 5
K142733 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 35d
Cleared Oct 28, 2014
E-CUBE 12
K142884 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 26d
Cleared Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh),...
K142900 · FTL
Sofradim Production
General & Plastic Surgery · 22d
Cleared Oct 27, 2014
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA...
K140225 · MOB
Phadia US, Inc.
Immunology · 271d
Cleared Oct 27, 2014
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
K140940 · JOJ
Canadian Technical Tape, Ltd.
General Hospital · 196d
Cleared Oct 27, 2014
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · JDI
Biomet, Inc.
Orthopedic · 159d
Cleared Oct 27, 2014
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
K141407 · MBH
Biomet, Inc.
Orthopedic · 152d
Cleared Oct 27, 2014
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K141809 · DRM
Defibtech, LLC
Cardiovascular · 112d
Cleared Oct 27, 2014
FLOSPINE PEDICLE SCREW SYSTEM
K141850 · NKB
Flospine
Orthopedic · 110d
Cleared Oct 27, 2014
ENDOSKELETON
K141953 · MAX
Titan Spine, LLC
Orthopedic · 101d
Cleared Oct 27, 2014
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
K142070 · FTM
Rti Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Oct 27, 2014
Xia® Growth Rod Conversion Set
K142114 · PGM
Stryker Corporation
Orthopedic · 84d
Cleared Oct 27, 2014
Uroflowmeter
K142425 · EXY
Be Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Oct 27, 2014
CD HORIZON Spinal System
K142847 · NKB
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 27d
Cleared Oct 24, 2014
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
K133069 · EFB
Codent Technical Industry Co., Ltd.
Dental · 389d
Cleared Oct 24, 2014
E-FIT EF-1280 EMS MACHINE
K133225 · NGX
Fit-Pro Kft , Ltd.
Physical Medicine · 368d
Cleared Oct 24, 2014
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS...
K140022 · OMP
Cork Medical Products, LLC
General & Plastic Surgery · 294d
Cleared Oct 24, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140647 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 225d
Cleared Oct 24, 2014
CLINPRO PROPHY POWDER
K140684 · PIP
3M Deutschland GmbH
Dental · 220d
Cleared Oct 24, 2014
UNIVERSAL NAVIGATION INSTRUMENTS
K140927 · OLO
Medos International SARL
Orthopedic · 196d