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
72985–73008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2003
PREPARE CARTRIDGE
K023890 · MRZ
Appro Healthcare, Inc.
General Hospital · 78d
Cleared Feb 07, 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
K024194 · NBW
Lifescan, Inc.
Chemistry · 49d
Cleared Feb 07, 2003
DIAMONDCOAT ULTRASONIC INSERTS
K030111 · ELC
Dentsply International
Dental · 25d
Cleared Feb 07, 2003
NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN...
K030126 · FLL
Norm Pacific Automation Corp.
General Hospital · 24d
Cleared Feb 07, 2003
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255 · LJS
C.R. Bard, Inc.
General Hospital · 14d
Cleared Feb 06, 2003
FASSIRE-DUVAL TELESCOPIC IM SYSTEM
K020885 · HSB
Pega Medical, Inc.
Orthopedic · 325d
Cleared Feb 06, 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
K021270 · GZJ
Biomedical Life Systems
Neurology · 290d
Cleared Feb 06, 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
K021271 · GZJ
Biomedical Life Systems
Neurology · 290d
Cleared Feb 06, 2003
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593 · JZO
Quest Intl., Inc.
Immunology · 104d
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