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
78673–78696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2001
ALPCO MILENIA ANTI-TG EIA
K011415 · JZO
American Laboratory Products Co., Ltd.
Immunology · 22d
Cleared May 29, 2001
VECTORSURGE 5, MODEL VS-500
K002058 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 327d
Cleared May 29, 2001
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K003630 · MVA
Danmar Products, Inc.
Neurology · 186d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · DIS
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
SCS CLOSED SCREW
K003733 · MNH
Ortho Tec, LLC
Orthopedic · 176d
Cleared May 29, 2001
SYNTHES SYNEX SPACER SYSTEM
K003836 · MQP
Synthes
Orthopedic · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d
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