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
88153–88176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1998
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
K981297 · LTK
Diagnostic Products Corp.
Immunology · 163d
Cleared Sep 18, 1998
KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
K982176 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 88d
Cleared Sep 18, 1998
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION...
K982182 · DXC
Radi Medical Systems AB
Cardiovascular · 88d
Cleared Sep 18, 1998
MANUAL RESUSCITATOR WITH ACE
K982215 · BTM
Medical Marketing Concepts
Anesthesiology · 87d
Cleared Sep 18, 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 18, 1998
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
K982496 · MOS
Medical Advances, Inc.
Radiology · 63d
Cleared Sep 18, 1998
MTEK-1400
K982846 · CCK
Magna Advanced Technologies, Inc.
Anesthesiology · 37d
Cleared Sep 17, 1998
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS...
K973448 · LGD
Beckman Instruments, Inc.
Microbiology · 371d
Cleared Sep 17, 1998
PERCUSSIVETECH HF, MODEL 2001
K981726 · NHJ
Vortran Medical Technology 1, Inc.
Anesthesiology · 125d
Cleared Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · DBM
Trace Scientific , Ltd.
Immunology · 93d
Cleared Sep 17, 1998
HAMAMATSU PET SCANNER, MODEL SHR-22000
K982171 · KPS
Hamamatsu Photonics K.K.
Radiology · 90d
Cleared Sep 17, 1998
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
K982179 · CAF
Trudell Medical
Anesthesiology · 87d
Cleared Sep 17, 1998
MTEK-1000
K982405 · DQA
Magna Advanced Technologies, Inc.
Anesthesiology · 69d
Cleared Sep 17, 1998
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 20d
Cleared Sep 16, 1998
EUROMEDICAL HAEMATURIA FOLEY CATHETER
K973076 · EZL
Unomedical Sdn Bhd
Gastroenterology & Urology · 394d
Cleared Sep 16, 1998
BIO-OSS COLLAGEN
K974399 · LYC
Geistlich-Pharma
Dental · 299d
Cleared Sep 16, 1998
ORAL POTENTIAL METER (OPM)
K982105 · LFC
Pertec of Wisconsin, Inc.
Dental · 92d
Cleared Sep 16, 1998
FAST-CATH INTRA-CARDIAC INTRODUCER
K982187 · DYB
Daig Corp.
Cardiovascular · 86d
Cleared Sep 16, 1998
MINI POLYURETHANE CATHETER
K982507 · LJT
Med Institute, Inc.
General Hospital · 58d
Cleared Sep 16, 1998
TBIL
K983133 · CIG
Abbott Laboratories
Chemistry · 8d
Cleared Sep 15, 1998
BIO-OSS ANORGANIC BOVINE BONE
K970321 · LYC
Geistlich-Pharma
Dental · 595d
Cleared Sep 15, 1998
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · MSE
Fresenius USA, Inc.
Gastroenterology & Urology · 567d
Cleared Sep 15, 1998
CLEAN SOURCE I, MODEL CS1000
K981144 · EIA
Aquarius Technologies, Inc.
Dental · 169d
Cleared Sep 15, 1998
BIOPAK MEASUREMENT SYSTEM
K981563 · KZM
Bio-Research Associates, Inc.
Dental · 137d