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
72745–72768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2003
CDS 3-PD HEMATOLOGY CONTROLS
K024173 · JPK
Clinical Diagnostic Solutions, Inc.
Hematology · 27d
Cleared Jan 14, 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 26d
Cleared Jan 13, 2003
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING)...
K021794 · GZJ
Tatung Co.
Neurology · 227d
Cleared Jan 13, 2003
BODY BOX 5500
K022636 · JEH
Morgan Scientific, Inc.
Anesthesiology · 158d
Cleared Jan 13, 2003
LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
K023163 · KMF
Medlogic Global Limited
General & Plastic Surgery · 112d
Cleared Jan 13, 2003
MEDS-4 NEUROMUSCULAR STIMULATOR
K023435 · GZJ
Medical Equipment Device Specialists
Neurology · 90d
Cleared Jan 13, 2003
MEDS-4 NEUROMUSCULAR STIMULATOR
K023439 · IPF
Medical Equipment Device Specialists
Physical Medicine · 90d
Cleared Jan 13, 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023443 · GZJ
Medical Equipment Device Specialists
Neurology · 90d
Cleared Jan 13, 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023446 · IPF
Medical Equipment Device Specialists
Physical Medicine · 90d
Cleared Jan 13, 2003
NON-INVASIVE PATIENT FIXATION SYSTEM
K023449 · IYE
Stryker Leibinger
Radiology · 90d
Cleared Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · OLW
Datex-Ohmeda
Neurology · 90d
Cleared Jan 13, 2003
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL...
K023462 · LXM
Neuromechanical Innovations, LLC
Physical Medicine · 90d
Cleared Jan 13, 2003
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
K023464 · GEX
Quantel Medical
General & Plastic Surgery · 90d
Cleared Jan 13, 2003
GOLD CORE PLUS
K023499 · EJH
Pentron Laboratory Technologies
Dental · 87d
Cleared Jan 13, 2003
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
K023572 · MVA
Rehabilitation Institute,Loma Linda...
Neurology · 81d
Cleared Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · LCP
Randox Laboratories, Ltd.
Chemistry · 66d
Cleared Jan 13, 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223 · LKJ
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
K024231 · DHN
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · LHI
Abbott Laboratories
General Hospital · 21d
Cleared Jan 10, 2003
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
K021739 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 227d
Cleared Jan 10, 2003
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078 · DRN
Sola Medical Devices, LLC
Cardiovascular · 198d
Cleared Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · DXT
Medrad, Inc.
Cardiovascular · 108d
Cleared Jan 10, 2003
BONART ART-L2 LIGHT CURING UNIT
K023721 · EBZ
Bonart Co., Ltd.
Dental · 66d
Cleared Jan 10, 2003
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT...
K023791 · LPL
Softfocal Company, Inc.
Ophthalmic · 58d