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
77065–77088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2001
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
K011861 · MOD
Cardiopulmonary Corp.
Anesthesiology · 145d
Cleared Nov 06, 2001
PF 5050 PRESSURE UNIT, MODEL PF 5050
K011899 · DPW
Perimed AB
Cardiovascular · 141d
Cleared Nov 06, 2001
SURESET INFUSION SET, MODEL 8023
K012429 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 98d
Cleared Nov 06, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
K012617 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Nov 06, 2001
SICKLE-CHEX
K013316 · GHM
Streck Laboratories, Inc.
Hematology · 33d
Cleared Nov 06, 2001
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 05, 2001
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
K002937 · LRT
Albert Browne , Ltd.
General Hospital · 410d
Cleared Nov 05, 2001
EVERSTICK
K011788 · EBI
Stick Tech , Ltd.
Dental · 150d
Cleared Nov 05, 2001
EVERSTICKNET
K011799 · EBI
Stick Tech , Ltd.
Dental · 150d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · DKZ
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Nov 05, 2001
ARAMIS DERMATLOGIC LASER
K012545 · GEX
Lumedics, Ltd.
General & Plastic Surgery · 90d
Cleared Nov 05, 2001
SCITON IMAGE HAIR REMOVAL LASER
K012552 · GEX
Sciton, Inc
General & Plastic Surgery · 89d
Cleared Nov 05, 2001
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
K012794 · EBF
Prime Dental Manufacturing, Inc.
Dental · 76d
Cleared Nov 05, 2001
THE V BAG, CATALOG NUMBER VB1800
K012942 · DTN
Circulatory Technology, Inc.
Cardiovascular · 66d
Cleared Nov 02, 2001
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439 · DSB
Cardiodynamics International Corp.
Cardiovascular · 176d
Cleared Nov 02, 2001
GLYCOSAL II HBA 1C TEST
K011933 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 135d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Nov 02, 2001
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · KNT
Zevex, Inc.
Gastroenterology & Urology · 115d
Cleared Nov 02, 2001
KADANCE 2000
K012492 · LBB
Kada Research, Inc.
Neurology · 91d
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · MSX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Nov 02, 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · HRX
Sterilmed, Inc.
Orthopedic · 87d
Cleared Nov 02, 2001
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
K012546 · KPR
Sedecal USA, Inc.
Radiology · 87d
Cleared Nov 02, 2001
DEEP GRAY
K012563 · LLZ
Cortechs Labs, Inc.
Radiology · 85d
Cleared Nov 02, 2001
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 84d