Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
79801–79824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · JXM
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · JXM
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014 · DJR
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015 · DJR
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
K010045 · LCM
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047 · LCM
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
K010079 · DOE
Alfa Scientific Designs, Inc.
Toxicology · 139d
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