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
72481–72504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2003
SYNAMPS2
K023771 · GWQ
Neuroscan
Neurology · 86d
Cleared Feb 06, 2003
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
K024031 · LJM
Theratest Laboratories, Inc.
Immunology · 62d
Cleared Feb 06, 2003
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
K024046 · EBD
Bisco, Inc.
Dental · 62d
Cleared Feb 06, 2003
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
K024151 · MQA
Theratest Laboratories, Inc.
Immunology · 62d
Cleared Feb 06, 2003
STEP-SAVER STAIRWAY CHAIRLIFT
K024167 · ILK
Services Industriels Savaria, Inc.
Physical Medicine · 51d
Cleared Feb 06, 2003
KOMPRESSOR SCREW SYSTEM
K024233 · HWC
Kinetikos Medical, Inc.
Orthopedic · 45d
Cleared Feb 06, 2003
BIOARC SP SLING KIT
K030123 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared Feb 06, 2003
OLYMPUS FERRITIN REAGENT
K030124 · DBF
Olympus America, Inc.
Immunology · 23d
Cleared Feb 06, 2003
SONOCALC
K030223 · LLZ
Sonometric Health, LLC
Radiology · 15d
Cleared Feb 05, 2003
REPROCESSED COMPRESSION SLEEVE
K021654 · JOW
Alliance Medical, Inc.
Cardiovascular · 261d
Cleared Feb 05, 2003
OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM
K022877 · LLZ
Vision Chips, Inc.
Radiology · 159d
Cleared Feb 05, 2003
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
K022959 · EJI
MDC Research , Ltd.
Dental · 152d
Cleared Feb 05, 2003
FRIOS ALGIPORE
K023799 · LYC
Friadent GmbH
Dental · 83d
Cleared Feb 05, 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879 · HRS
Synthes (Usa)
Orthopedic · 76d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP...
K023946 · DIS
ACON Laboratories, Inc.
Toxicology · 70d
Cleared Feb 05, 2003
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K023994 · MNH
Ortho Tec, LLC
Orthopedic · 64d
Cleared Feb 05, 2003
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT...
K024003 · LPL
Gelflex
Ophthalmic · 63d
Cleared Feb 05, 2003
NESS CHILDREN SYSTEM
K024279 · IPG
Ness-Neuromuscular Electrical...
Physical Medicine · 44d
Cleared Feb 05, 2003
UNIVERSAL TOTAL WRIST SYSTEM
K030037 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
HA PMI FEMORAL HIP STEM
K030048 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
SPINEMED
K030060 · ITH
Cert Health Sciences, LLC
Physical Medicine · 29d
Cleared Feb 05, 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079 · LPH
Zimmer, Inc.
Orthopedic · 27d
Cleared Feb 05, 2003
CARDIUS-1 AND CARDIS-2
K030085 · KPS
Digirad Corp.
Radiology · 27d