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
91105–91128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1998
MILLS INCUS HA SLEEVE
K974365 · ETB
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 64d
Cleared Jan 22, 1998
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW...
K974471 · LJT
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jan 22, 1998
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
K974699 · DKB
Consolidated Technologies, Inc.
Toxicology · 37d
Cleared Jan 22, 1998
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
K974822 · JJY
Avl Scientific Corp.
Chemistry · 29d
Cleared Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
K974826 · JJY
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Jan 22, 1998
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
K974851 · JHI
San Diego Biotech
Chemistry · 24d
Cleared Jan 22, 1998
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859 · CFJ
Diagnostic Chemicals , Ltd.
Chemistry · 24d
Cleared Jan 21, 1998
DEPUY AMK 3 PEG PATELLA
K972643 · JWH
Depuy, Inc.
Orthopedic · 190d
Cleared Jan 21, 1998
QUEST PET IMAGING SYSTEM
K973396 · KPS
Ugm Medical Systems, Inc.
Radiology · 149d
Cleared Jan 21, 1998
NURSE'S AID PATIENT ROTATION SYSTEM
K973624 · IOQ
Air Med Assist Products
Physical Medicine · 120d
Cleared Jan 21, 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jan 21, 1998
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
K974028 · MKO
Conceptus, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 21, 1998
CARPAL ENGAGING WRIST FUSION PLATE
K974030 · HRS
Terray Corp.
Orthopedic · 90d
Cleared Jan 21, 1998
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
K974056 · CAF
Holopack International, LP
Anesthesiology · 86d
Cleared Jan 21, 1998
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
K974107 · LMD
Eastman Kodak Company
Radiology · 82d
Cleared Jan 21, 1998
STEALTHSTATION SYSTEM
K974187 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 131d
Cleared Jan 21, 1998
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE,...
K974312 · KNW
Telemed Systems, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 20, 1998
MEDPOR OCULAR CONFORMER
K972034 · HQN
Porex Surgical, Inc.
Ophthalmic · 232d
Cleared Jan 20, 1998
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
K972385 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 208d
Cleared Jan 20, 1998
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI...
K972614 · CAW
Healthdyne Technologies, Inc.
Anesthesiology · 190d
Cleared Jan 20, 1998
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · FHN
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 20, 1998
VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.
K974077 · EHD
J. Morita USA, Inc.
Radiology · 83d
Cleared Jan 20, 1998
KODAK DIGITAL SCIENCE CARDIAC VIEWER
K974086 · LLZ
Eastman Kodak Company
Radiology · 83d
Cleared Jan 20, 1998
MILTRA IMAGING INC., IMAGE VAULT
K974102 · LMD
Mitra Imaging, Inc.
Radiology · 81d