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
105145–105168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1994
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K944944 · FCG
Promedical , Ltd.
Gastroenterology & Urology · 75d
Cleared Dec 21, 1994
BRONCHOSCOPE,NON-RIGID
K944976 · EOQ
Citation Medical Corp.
Ear, Nose, Throat · 71d
Cleared Dec 21, 1994
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K945146 · FCG
Promex, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 21, 1994
ACTIVE MODEL CIC
K945218 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 56d
Cleared Dec 21, 1994
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
K945237 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Dec 21, 1994
FINETONE DISCEET CANAL
K945780 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 26d
Cleared Dec 21, 1994
EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS
K945975 · GEI
Everest Medical Corp.
General & Plastic Surgery · 13d
Cleared Dec 21, 1994
TROCAR/CANNULA
K945979 · GCJ
Endoscopic Technologies, Inc.
General & Plastic Surgery · 13d
Cleared Dec 20, 1994
WINNER SELF-TAKING HOME BLOOD PRESSURE KIT
K942163 · DXN
Winmed Instruments Mfg. Corp.
Cardiovascular · 230d
Cleared Dec 20, 1994
OREX O.R. TOWEL
K942228 · KKX
Thantex Specialties, Inc.
General Hospital · 228d
Cleared Dec 20, 1994
PROSTHOFLEX
K942562 · EBI
Knopf Assoc, Inc.
Dental · 203d
Cleared Dec 20, 1994
BONE SCREW WASHER
K943782 · HTN
Acu Med, Inc.
Orthopedic · 139d
Cleared Dec 20, 1994
TRANSTIBIAL ACL DISPOSABLES KIT
K943943 · HRX
Arthrex, Inc.
Orthopedic · 131d
Cleared Dec 20, 1994
FOCUS BALLOON DILATATION CATHETER
K944016 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 126d
Cleared Dec 20, 1994
JENERIC/PENTRON P0WERED TOOTHBRUST
K944084 · JEQ
Jeneric/Pentron, Inc.
Dental · 120d
Cleared Dec 20, 1994
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · FYA
Baxter Healthcare Corp
General Hospital · 118d
Cleared Dec 20, 1994
PRIMED RIGID CONTAINER SYSTEM
K944864 · KCT
Primed, Inc.
General Hospital · 78d
Cleared Dec 20, 1994
CG DISPOSABLE SYRINGE
K944920 · FMF
Fortunique Medical Products
General Hospital · 75d
Cleared Dec 20, 1994
KLENZYME
K944950 · FLG
Calgon Corp.
General Hospital · 74d
Cleared Dec 20, 1994
INFRA VISION IMAGING SYSTEM
K945297 · GCJ
Gabriel Medical, Inc.
General & Plastic Surgery · 50d
Cleared Dec 20, 1994
SUPER POLI-GRIP DENTURE ADHESIVE CREAM
K945462 · KOT
Block Drug Company, Inc.
Dental · 43d
Cleared Dec 20, 1994
CVD SMALL VESSEL BALLOON DILATATION CATHETER
K945465 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 43d
Cleared Dec 20, 1994
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K946023 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 11d
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · LFX
Abbott Laboratories
Microbiology · 658d