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
98545–98568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1996
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
K954952 · MOS
Medrad, Inc.
Radiology · 135d
Cleared Mar 13, 1996
HYDROLOGY 5000
K955339 · GBX
Northgate Technologies, Inc.
General & Plastic Surgery · 114d
Cleared Mar 13, 1996
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680 · JOH
Mallinckrodt Medical
Anesthesiology · 90d
Cleared Mar 13, 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · JPA
Sigma Diagnostics, Inc.
Hematology · 86d
Cleared Mar 13, 1996
EBI ANTERIOR CERVICAL SPINE SYSTEM
K955730 · KWQ
Electro-Biology, Inc.
Orthopedic · 86d
Cleared Mar 13, 1996
TIBIA ORTHONAIL
K955761 · HSB
Orthologic Corp.
Orthopedic · 86d
Cleared Mar 13, 1996
ALBUMIN
K955781 · CIX
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Mar 13, 1996
ALLDRESS MULTI LAYERED WOUND DRESSING
K955863 · NAD
Molnlycke/Scott Health Care
General & Plastic Surgery · 77d
Cleared Mar 13, 1996
COORDINATE REVISION KNEE SYSTEM
K955884 · JWH
Depuy, Inc.
Orthopedic · 76d
Cleared Mar 13, 1996
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
K955927 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 82d
Cleared Mar 13, 1996
CALCIUM REAGENT
K955939 · CIC
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Mar 13, 1996
TOTAL BILIRUBIN REAGENT
K955940 · CIG
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Mar 13, 1996
SPECTRUM DESIGNS SILICONE BLOCK
K960038 · MIB
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Mar 13, 1996
PSA CONTROLS
K960154 · JJX
Diagnostic Products Corp.
Immunology · 57d
Cleared Mar 13, 1996
PERMARIDGE HYDROXYLAPATITE MATRIX
K960349 · FWP
Ceramed Corp.
General & Plastic Surgery · 48d
Cleared Mar 12, 1996
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · LQL
Biomerieux Vitek, Inc.
Microbiology · 313d
Cleared Mar 12, 1996
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
K953392 · BTT
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 237d
Cleared Mar 12, 1996
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
K954006 · GKL
Intl. Remote Imaging Systems
Hematology · 200d
Cleared Mar 12, 1996
HYSTEROSCOPE
K954164 · HIH
Conceptus, Inc.
Obstetrics & Gynecology · 189d
Cleared Mar 12, 1996
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415 · LYY
Hartalega Sdn Bhd
General Hospital · 173d
Cleared Mar 12, 1996
SURGICAL CAP
K954556 · FYF
Thai Disposable Products Co., Ltd.
General & Plastic Surgery · 162d
Cleared Mar 12, 1996
DRYTIME FOR POTTY TRAINING
K955338 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 112d
Cleared Mar 12, 1996
STERITEC CROSS-CHECKS
K955426 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 105d
Cleared Mar 12, 1996
CATH-GUIDE
K955645 · BSY
Hudson Respiratory Care, Inc.
Anesthesiology · 91d