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
80545–80568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Dec 27, 2000
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K003815 · INI
Merits Health Products., Inc.
Physical Medicine · 16d
Cleared Dec 26, 2000
CRYOSURGICAL UNIT AND ACCESSORIES
K003050 · GEI
Cryogen, Inc.
General & Plastic Surgery · 85d
Cleared Dec 26, 2000
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · DCN
Diagnostic Products Corp.
Immunology · 57d
Cleared Dec 26, 2000
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
K003677 · GKZ
Abx Diagnostics
Hematology · 27d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Dec 22, 2000
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
K001955 · GEI
Aaron Medical Industries
General & Plastic Surgery · 178d
Cleared Dec 22, 2000
BIOTEQ I.V. (INTRAVENOUS) SET
K002449 · FPA
Bioteque Corp.
General Hospital · 135d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER,...
K002976 · DRF
St Jude Medical
Cardiovascular · 88d
Cleared Dec 22, 2000
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL...
K003036 · KYG
Retinalabs.Com
Ophthalmic · 84d
Cleared Dec 22, 2000
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K003134 · KGN
Adri/Technam
General & Plastic Surgery · 77d
Cleared Dec 22, 2000
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · JIF
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Dec 22, 2000
EHC400 DESKTOP PATIENT STATION
K003257 · CGA
Cybercare Technologies, Inc.
Chemistry · 65d
Cleared Dec 22, 2000
CLEANAIR/ CLEANWATER UNIT, MODEL 1600
K003265 · EIA
Texas Institute For Conservative...
Dental · 65d
Cleared Dec 22, 2000
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270 · JAQ
Nucletron Corp.
Radiology · 65d
Cleared Dec 22, 2000
PEDIATRIC INGESTASCAN
K003305 · HPM
Adams Electronics, Inc.
Ophthalmic · 63d
Cleared Dec 22, 2000
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
K003366 · MOS
Igc-Medical Advances, Inc.
Radiology · 53d
Cleared Dec 22, 2000
DW 276 #3
K003635 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · MOS
Medical Advances, Inc.
Radiology · 22d
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II...
K003687 · DKE
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Dec 22, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
K003769 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 16d
Cleared Dec 22, 2000
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000,...
K003790 · GCJ
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Dec 22, 2000
GE ADVANCE NXI PET SYSTEM
K003849 · KPS
Ge Medical Systems, Inc.
Radiology · 10d
Cleared Dec 22, 2000
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 368d