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
73753–73776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
K022936 · JJY
Cliniqa Corporation
Chemistry · 28d
Cleared Oct 02, 2002
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K022953 · MUH
Schick Technologies, Inc.
Radiology · 27d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · JDI
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 02, 2002
PROXILOCK HIP PROSTHESIS
K022966 · LWJ
Implex Corp.
Orthopedic · 26d
Cleared Oct 02, 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · FMF
Wrightmedicaltechnologyinc
General Hospital · 15d
Cleared Oct 02, 2002
BREATHABLE SURGICAL GOWN
K023167 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Oct 01, 2002
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR...
K011493 · KPT
Mentor Corp.
Radiology · 504d
Cleared Oct 01, 2002
PMX DISPOSABLE BAG MASK RESUSCITATOR
K014071 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 295d
Cleared Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · LOJ
Bayer Diagnostics Corp.
Immunology · 203d
Cleared Oct 01, 2002
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
K021142 · EZL
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 175d
Cleared Oct 01, 2002
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
K021389 · DQD
Andromed, Inc.
Cardiovascular · 152d
Cleared Oct 01, 2002
UNITY NETWORK ID
K021454 · MWI
General Electric Medical Systems...
Cardiovascular · 148d
Cleared Oct 01, 2002
QIVA
K021495 · DQK
Pie Medical Imaging BV
Cardiovascular · 145d
Cleared Oct 01, 2002
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
K022181 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Oct 01, 2002
I-STETHOS LINK
K022298 · DQD
Andromed, Inc.
Cardiovascular · 77d
Cleared Oct 01, 2002
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380 · DRF
St Jude Medical
Cardiovascular · 71d
Cleared Oct 01, 2002
SPIFE LD-12 KIT, MODEL 3338
K022455 · CFE
Helena Laboratories
Chemistry · 67d
Cleared Oct 01, 2002
SNIFF POSITION PILLOWS/POPITZ PILLOWS
K023010 · MYB
Aeolus International Corporation
Ear, Nose, Throat · 22d
Cleared Sep 30, 2002
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
K012138 · MYA
Chroma Vision Medical Systems, Inc.
Pathology · 447d
Cleared Sep 30, 2002
BIO-RAD PLATELIA TOXO IGM TMB
K013837 · LGD
Bio-Rad
Microbiology · 315d
Cleared Sep 30, 2002
BIO-RAD PLATELIA TOXO IGG TMB
K013839 · LGD
Bio-Rad
Microbiology · 315d
Cleared Sep 30, 2002
WHISPER WEAR BREAST PUMP
K022140 · HGX
Whisper Wear
Obstetrics & Gynecology · 90d
Cleared Sep 30, 2002
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
K022154 · IXW
Fischer Industries, Inc.
Radiology · 90d
Cleared Sep 30, 2002
EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
K022406 · FMI
Exelint Intl. Co.
General Hospital · 69d