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
78937–78960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2001
SURE CHECK OVULATION PREDICTOR
K010244 · CEP
Chembio Diagnostic Systems, Inc.
Chemistry · 97d
Cleared May 02, 2001
WEISS RETINAL CANNULA
K010305 · HMX
Micron Surgical, Inc.
Ophthalmic · 90d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · KTW
Synthes (Usa)
Orthopedic · 89d
Cleared May 02, 2001
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K010322 · HSB
Orthodyne, Inc.
Orthopedic · 89d
Cleared May 02, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 86d
Cleared May 02, 2001
ECLIPSE 6.5
K010975 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared May 02, 2001
WHITE MTA MATERIAL
K011009 · KIF
Dentsply International
Dental · 28d
Cleared May 02, 2001
BIOUNIVERSAL PDF
K011022 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
D.SIGN 96
K011023 · EJT
Ivoclar North America, Inc.
Dental · 28d
Cleared May 02, 2001
SIII ALARM AMPLIFIER
K011088 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared May 02, 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007,...
K011115 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 20d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126 · JIT
Hemagen Diagnostics, Inc.
Chemistry · 19d
Cleared May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · DIO
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 01, 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED)...
K002718 · LYY
Tillotson Healthcare Corp.
General Hospital · 243d
Cleared May 01, 2001
SPHYGMOCOR MX MODEL SCOR-MX
K002742 · DSK
Pwv Medical Pty, Lt.
Cardiovascular · 242d
Cleared May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · DDG
Roche Diagnostics Corp.
Immunology · 211d
Cleared May 01, 2001
WELCON STERILE WATER FOR DEVICE IRRIGATION
K003402 · JOL
Welcon, Inc.
General Hospital · 181d
Cleared May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K010284 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared May 01, 2001
DRX 2000
K010292 · ITH
Axiom Worldwide, Inc.
Physical Medicine · 90d
Cleared May 01, 2001
COOLTOUCH VARIA ND:YAG LASER SYSTEM
K010316 · GEX
Cooltouch Corp.
General & Plastic Surgery · 88d
Cleared May 01, 2001
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING...
K010438 · KGO
Terang Nusa Sdn Bhd
General Hospital · 77d
Cleared May 01, 2001
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING...
K010439 · KGO
Terang Nusa Sdn Bhd
General Hospital · 78d
Cleared May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K010494 · JPA
Dade Behring, Inc.
Hematology · 70d
Cleared May 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVE
K011012 · LZA
Contract Latex Dippers Sdn Bhd
General Hospital · 27d