Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69001–69024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2004
DURABRAID SUTURE
K040789 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 67d
Cleared Jun 04, 2004
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868 · FTM
Genzyme Corp.
General & Plastic Surgery · 63d
Cleared Jun 04, 2004
POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
K041048 · NEW
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 43d
Cleared Jun 04, 2004
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
K041179 · FPA
Medegen Medical Manufacturing...
General Hospital · 29d
Cleared Jun 04, 2004
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
K041235 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 24d
Cleared Jun 04, 2004
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K041347 · GEI
Neothermia Corp.
General & Plastic Surgery · 15d
Cleared Jun 04, 2004
MODIFICATION TO M2376A DEVICELINK SYSTEM
K041401 · MWI
Philips Medical Systems
Cardiovascular · 9d
Cleared Jun 03, 2004
LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES
K032767 · FPA
Lily Medical Supplies Co., Ltd.
General Hospital · 272d
Cleared Jun 03, 2004
PROCYON SPINAL SYSTEM
K033512 · MNH
Nas Medical Technologies, Inc.
Orthopedic · 210d
Cleared Jun 03, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
K033711 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Jun 03, 2004
COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
K033743 · DKZ
Cozart Bioscience , Ltd.
Toxicology · 188d
Cleared Jun 03, 2004
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K033790 · FLL
Tecnimed S.R.L.
General Hospital · 182d
Cleared Jun 03, 2004
ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN...
K040071 · LYZ
Elite International, Inc.
General Hospital · 141d
Cleared Jun 03, 2004
PSI-TEC PERISTALTIC INFILTRATION PUMP
K040149 · FRN
Byron Medical
General Hospital · 132d
Cleared Jun 03, 2004
QUICKELISA ANTHRAX-PA KIT
K040407 · NRL
Immunetics, Inc.
Microbiology · 107d
Cleared Jun 03, 2004
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K040458 · MHX
Ge Medical Systems Information...
Cardiovascular · 101d
Cleared Jun 03, 2004
MODIFICATION TO AVANT 9600 PULSE OXIMETER
K040589 · DQA
Nonin Medical, Inc.
Anesthesiology · 87d
Cleared Jun 03, 2004
BONAMATES SERIES
K040650 · JEY
Biotech One, Inc.
Dental · 84d
Cleared Jun 03, 2004
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040681 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 79d
Cleared Jun 03, 2004
AIR SAFETY HEPA, MODEL 3500
K040712 · MOD
Air Safety, Ltd.
Anesthesiology · 77d
Cleared Jun 03, 2004
SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55...
K040720 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 76d
Cleared Jun 03, 2004
VENTLAB NASAL CPAP CANNULA
K040726 · BZD
Ventlab Corp.
Anesthesiology · 73d
Cleared Jun 03, 2004
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
K040790 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 66d
Cleared Jun 03, 2004
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K040791 · LZA
Pt. Smartglove Indonesia
General Hospital · 66d