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

Filters: Cleared only ×
176,076 results
82681–82704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894 · LNH
Biosound Esaote, Inc.
Radiology · 15d
Cleared Jul 06, 2000
LOOP ELECTRODE, BALL ELECTRODE
K993527 · HGI
Palm Medical USA, Inc.
Obstetrics & Gynecology · 262d
Cleared Jul 06, 2000
MEDISANA DIGITAL TENS
K994265 · GZJ
Fuji Dynamics Limited
Neurology · 202d
Cleared Jul 06, 2000
FDTENS 2010
K994266 · GZJ
Fuji Dynamics Limited
Neurology · 202d
Cleared Jul 05, 2000
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD...
K000901 · FYA
Molnlycke Health Care, Inc.
General Hospital · 106d
Cleared Jul 05, 2000
CRYSTAL-EEG MODEL 15
K001110 · OMC
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared Jul 05, 2000
COMFORT STIM
K001117 · GXY
R & D Medical Products, Inc.
Neurology · 90d
Cleared Jul 05, 2000
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
K001137 · CAF
Trudell Medical Int'L
Anesthesiology · 86d
Cleared Jul 05, 2000
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K001165 · LYY
Medipure Corporation (M) Sdn. Bhd.
General Hospital · 86d
Cleared Jul 05, 2000
CORRECT PLUS
K001218 · ELW
Jeneric/Pentron, Inc.
Dental · 79d
Cleared Jul 05, 2000
DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
K001337 · MMK
The Daniels Corp.
General Hospital · 69d
Cleared Jul 05, 2000
SUPREMCAST V
K001383 · EJH
American Dent-All, Inc.
Dental · 64d
Cleared Jul 05, 2000
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
K001418 · EIH
Procera Sandvik, Inc.
Dental · 61d
Cleared Jul 05, 2000
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 61d
Cleared Jul 05, 2000
DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
K001432 · LYZ
Shanghai PM Plastics Ent. Co., Ltd.
General Hospital · 58d
Cleared Jul 05, 2000
R&D PROJECT DW269#25
K001469 · EJS
Ivoclar North America, Inc.
Dental · 56d
Cleared Jul 05, 2000
GRADIA
K001518 · EBF
GC America, Inc.
Dental · 50d
Cleared Jul 05, 2000
POWDERED PATIENT EXAMINATION GLOVES, LATEX
K001715 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 30d
Cleared Jul 05, 2000
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
K001758 · JJY
Medical Analysis Systems, Inc.
Chemistry · 26d
Cleared Jul 05, 2000
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
K001770 · DQA
Bci, Inc.
Anesthesiology · 23d
Cleared Jul 05, 2000
MALLINCKRODT, GOODKNIGHT 418S
K001845 · BZD
Mallinckrodt Developpement France
Anesthesiology · 16d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089 · FMF
Baxter Healthcare Corp
General Hospital · 833d
Cleared Jul 05, 2000
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
K983667 · MQP
Ionics Medical Corp.
Orthopedic · 625d
Cleared Jul 05, 2000
INSTANT-VIEW MORPHINE URINE CASSETTE TEST
K994404 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 190d