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
72961–72984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2002
OCCLUFAST ROCK
K024034 · ELW
Zhermack S.P.A.
Dental · 12d
Cleared Dec 18, 2002
ZETAPLUS SOFT
K024041 · ELW
Zhermack S.P.A.
Dental · 12d
Cleared Dec 18, 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102 · LYY
Allegiance Healthcare Corp.
General Hospital · 6d
Cleared Dec 18, 2002
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
K024108 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 5d
Cleared Dec 17, 2002
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
K020683 · KXK
Ati Medical, Inc.
Radiology · 288d
Cleared Dec 17, 2002
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
K022028 · KPJ
Vascular One, Inc.
General & Plastic Surgery · 179d
Cleared Dec 17, 2002
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177 · LTJ
Bayer Diagnostics Corp.
Immunology · 167d
Cleared Dec 17, 2002
UNIVERSAL CMF SYSTEM
K022185 · JEY
Stryker Instruments
Dental · 167d
Cleared Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA...
K022288 · LTJ
Bayer Corp.
Immunology · 155d
Cleared Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · CDZ
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094 · HQF
Quantel Medical
Ophthalmic · 90d
Cleared Dec 17, 2002
PROSOLV CARDIVASCULAR VIEWER
K023112 · DQK
Problem Solving Concepts, Inc.
Cardiovascular · 89d
Cleared Dec 17, 2002
JOSTRA MECC SYSTEM
K023132 · KFM
Jostra AG
Cardiovascular · 88d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Dec 17, 2002
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
K023185 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 84d
Cleared Dec 17, 2002
STERI-SPOUTS
K023539 · LHI
Valumed
General Hospital · 56d
Cleared Dec 17, 2002
ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
K023560 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 55d
Cleared Dec 17, 2002
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
K023867 · JJY
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · LOJ
Tosoh Medics, Inc.
Immunology · 25d
Cleared Dec 17, 2002
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · GEI
Arthrex, Inc.
General & Plastic Surgery · 15d
Cleared Dec 16, 2002
KERATOME BLADE 200200 & 600600
K020482 · HNO
Micro Specialties, Inc.
Ophthalmic · 306d
Cleared Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
K021699 · LYL
Autolens, Inc.
Ophthalmic · 208d
Cleared Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · JHI
Sa Scientific, Inc.
Chemistry · 126d
Cleared Dec 16, 2002
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000,...
K022762 · DQX
Jomed, Inc.
Cardiovascular · 118d