FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89905–89928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337 · LJM
Helix Diagnostics, Inc.
Immunology · 104d
Cleared May 12, 1998
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12...
K980530 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 90d
Cleared May 12, 1998
COLOSCREEN-ES
K980671 · KHE
Helena Laboratories
Hematology · 81d
Cleared May 12, 1998
ULTRA-BLASTER
K980726 · KOJ
Ultradent Products, Inc.
Dental · 77d
Cleared May 12, 1998
SERAQUEST ANTI-SSA
K980810 · LJM
Quest Intl., Inc.
Immunology · 70d
Cleared May 12, 1998
SERAQUEST ANTI-SM/RNP
K980811 · LKP
Quest Intl., Inc.
Immunology · 70d
Cleared May 12, 1998
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
K980857 · MKJ
Graphic Controls Corp.
Cardiovascular · 68d
Cleared May 12, 1998
HEMOCOR HPH MINI HEMOCONCENTRATOR
K980859 · KDI
Minntech Corp.
Gastroenterology & Urology · 68d
Cleared May 12, 1998
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 50d
Cleared May 12, 1998
CO2
K981231 · KHS
Abbott Mfg., Inc.
Chemistry · 39d
Cleared May 12, 1998
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
K981256 · FAS
Ximed/Prosure/Injectx
Gastroenterology & Urology · 40d
Cleared May 12, 1998
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
K981425 · GKF
Nova Biomedical Corp.
General & Plastic Surgery · 26d
Cleared May 12, 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426 · GKF
Nova Biomedical Corp.
Hematology · 26d
Cleared May 12, 1998
STAT PROFILE M ANALYZER
K981427 · GKF
Nova Biomedical Corp.
Hematology · 26d
Cleared May 12, 1998
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
K981532 · JJY
Bio-Rad
Chemistry · 13d
Cleared May 11, 1998
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP...
K973561 · FOZ
Medical Components, Inc.
General Hospital · 234d
Cleared May 11, 1998
HERNIAMESH SURGICAL MESHES
K973955 · FTL
Herniamesh
General & Plastic Surgery · 207d
Cleared May 11, 1998
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR,...
K974038 · JCX
A & A Medical, Inc.
General & Plastic Surgery · 199d
Cleared May 11, 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
K974560 · DQX
Cordis Corp.
Cardiovascular · 157d
Cleared May 11, 1998
EXTENTRAC
K980021 · JFB
Advanced Back Technologies
Physical Medicine · 126d
Cleared May 11, 1998
C/T MED-SYSTEMS CASSETTE SYSTEM
K980065 · KCT
C/T Med System, Ltd.
General Hospital · 124d
Cleared May 11, 1998
LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW
K980512 · JEY
Walter Lorenz Surgical, Inc.
Dental · 90d
Cleared May 11, 1998
DEPUY ORTHOTECH CATERA SUTURE ANCHOR
K980595 · MBI
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared May 11, 1998
CARDIOSTATION
K980624 · DXH
Universal Medical, Inc.
Cardiovascular · 82d