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
73033–73056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2003
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
K020318 · FRO
Scivolutions, Inc.
General & Plastic Surgery · 369d
Cleared Feb 03, 2003
RADIUS MICRO SNARE
K022201 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 213d
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · FRO
Coloplast Corp.
General & Plastic Surgery · 194d
Cleared Feb 03, 2003
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
K022483 · FRO
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 189d
Cleared Feb 03, 2003
WATERLASE FOR APICOECTOMY
K022803 · MXF
Biolase Technology, Inc.
Dental · 164d
Cleared Feb 03, 2003
REPROCESSED EXTERNAL FIXATION DEVICE
K023714 · KTT
Alliance Medical Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
K023724 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
K023725 · GDW
Marina Medical Instruments, Inc.
General & Plastic Surgery · 89d
Cleared Feb 03, 2003
SIASCOPE II
K023729 · PSN
Astron Clinica Limited
General & Plastic Surgery · 89d
Cleared Feb 03, 2003
POWDERED VINYL EXAMINATION GLOVES
K024016 · LYZ
Top Glove (Zhangjiagang) Co. , Ltd.
General Hospital · 61d
Cleared Feb 03, 2003
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 49d
Cleared Feb 03, 2003
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
K024355 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 35d
Cleared Feb 03, 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Feb 03, 2003
THERMACOOL TC SYSTEM
K030142 · GEI
Thermage, Inc.
General & Plastic Surgery · 19d
Cleared Jan 31, 2003
RADIOMED MARKER
K022326 · JAK
Radiomed Corporation
Radiology · 197d
Cleared Jan 31, 2003
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
K022596 · DQK
Clover Hi-Tech, Inc.
Cardiovascular · 179d
Cleared Jan 31, 2003
RTDOSEPLAN
K022961 · MUJ
Math Resolutions, LLC
Radiology · 147d
Cleared Jan 31, 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · GKR
International Technidyne Corp.
Hematology · 100d
Cleared Jan 31, 2003
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K023712 · DKZ
Advantage Diagnostics Corp.
Toxicology · 88d
Cleared Jan 31, 2003
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
K023792 · JIX
Thermo Orion
Chemistry · 79d
Cleared Jan 31, 2003
AHL GENERIC GLASS IONOMER LUTING CEMENT
K023981 · EMA
Advanced Healthcare , Ltd.
Dental · 60d
Cleared Jan 31, 2003
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160...
K023984 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 60d
Cleared Jan 31, 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · DTB
Oscor, Inc.
Cardiovascular · 53d
Cleared Jan 31, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · LON
Becton, Dickinson & CO
Microbiology · 45d