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
79201–79224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
K010080 · DOE
Alfa Scientific Designs, Inc.
Toxicology · 139d
Cleared May 29, 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · DIS
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
MEDISYSTEMS LUER ACCESS INJECTION SITE
K010279 · FPA
Medisystems Corp.
General Hospital · 119d
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · LAF
Microgenics Corp.
Toxicology · 97d
Cleared May 29, 2001
DJ ORTHOPEDICS POST SCREW
K010594 · HWC
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · DCK
Beckman Coulter, Inc.
Chemistry · 90d
Cleared May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · GHH
Roche Diagnostics Corp.
Hematology · 46d
Cleared May 29, 2001
ALANTE, BATTERY OPERATED POWER WHEELCHAIR
K011153 · ITI
Golden Technologies, Inc.
Physical Medicine · 43d
Cleared May 29, 2001
OB-1 FETAL MONITOR
K011304 · HGM
Analogic Corp.
Obstetrics & Gynecology · 29d
Cleared May 29, 2001
GOLD CORE 73 LS
K011362 · EJT
Jeneric/Pentron, Inc.
Dental · 26d
Cleared May 29, 2001
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
K011369 · MEG
Safety Syringes, Inc.
General Hospital · 25d
Cleared May 29, 2001
JEWEL MPS
K011374 · IOR
Vestil Manufacturing Corp.
Physical Medicine · 25d
Cleared May 25, 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505 · MOS
Mri Devices Corp.
Radiology · 193d
Cleared May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
K010554 · HWC
Bionx Implants, Inc.
Orthopedic · 88d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · MQV
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared May 25, 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · MNI
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · MGQ
Ambu, Inc.
General & Plastic Surgery · 87d
Cleared May 25, 2001
GOODNET
K010763 · LLZ
Goodman Co., Ltd.
Radiology · 72d
Cleared May 25, 2001
SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT...
K010947 · LYY
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 57d
Cleared May 25, 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · LYZ
Allegiance Healthcare Corp.
General Hospital · 37d
Cleared May 25, 2001
RADIUS COUGAR WIRE
K011287 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 28d
Cleared May 25, 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT...
K011376 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 21d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · ERL
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared May 24, 2001
HEMODIALYSIS TUBING SETS
K001971 · FIB
Ofi Biomedica S.P.A.
Gastroenterology & Urology · 330d