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
89401–89424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 11, 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
K980645 · LNH
Philips Medical Systems North...
Radiology · 81d
Cleared May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared May 11, 1998
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · GAM
Aesculap, Inc.
General & Plastic Surgery · 77d
Cleared May 11, 1998
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
K980741 · HQD
Polymer Technology Div. Wilmington...
Ophthalmic · 74d
Cleared May 11, 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · LMA
Lumisys, Inc.
Radiology · 69d
Cleared May 11, 1998
SURGIDEV SILICONE PUNCTUM PLUG
K980844 · LZU
Advanced Vision Science
Ophthalmic · 68d
Cleared May 11, 1998
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
K980863 · KMF
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 67d
Cleared May 11, 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · IPF
Alive, Inc.
Physical Medicine · 63d
Cleared May 11, 1998
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
K980928 · KWP
Synthes Spine
Orthopedic · 61d