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
77809–77832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2001
SECURCUT ASPIRATION BIOPSY NEEDLE
K013071 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · LEH
Beckman Coulter, Inc.
Toxicology · 89d
Cleared Dec 12, 2001
SAS STREPALERT
K013379 · GTY
Sa Scientific, Inc.
Microbiology · 61d
Cleared Dec 12, 2001
PULPDENT CAVITY PREPARATION IV
K013411 · LBH
Pulpdent Corp.
Dental · 58d
Cleared Dec 12, 2001
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
K013423 · JWY
Dade Microscan, Inc.
Microbiology · 71d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Dec 12, 2001
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN,...
K013767 · FRN
Sterling Medivations, Inc.
General Hospital · 29d
Cleared Dec 12, 2001
MICROJET QUARK, MODEL U100 OR U40
K013807 · LZG
Cane S.R.L.
General Hospital · 27d
Cleared Dec 11, 2001
KNIGHTSTAR 330 VENTILATOR
K003075 · MNT
Mallinckrodt, Inc.
Anesthesiology · 434d
Cleared Dec 11, 2001
SONDREX P.A.L. SYSTEM
K010388 · HCC
Ohmeda Medical
Neurology · 306d
Cleared Dec 11, 2001
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH...
K010443 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 300d
Cleared Dec 11, 2001
H.M.T. ACUPUNCTURE NEEDLE
K012501 · MQX
Hummingbird Medical Technology, LLC
General Hospital · 130d
Cleared Dec 11, 2001
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
K012583 · MQX
Helio Medical Supplies, Inc.
General Hospital · 123d
Cleared Dec 11, 2001
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE...
K012587 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 11, 2001
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762 · HRY
Osteoimplant Technology, Inc.
Orthopedic · 116d
Cleared Dec 11, 2001
GRIP LOCK ANCHOR, MODEL 411374
K013063 · GZB
Medtronic Neurological
Neurology · 90d
Cleared Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · MND
Olympus America, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · MSX
Datex-Ohmeda
Cardiovascular · 74d
Cleared Dec 11, 2001
INTERA I/T
K013344 · LNH
Philips Medical Systems North America...
Radiology · 63d
Cleared Dec 11, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K013788 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 27d
Cleared Dec 11, 2001
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K013792 · DQA
Masimo Corp.
Anesthesiology · 27d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · HWC
United States Surgical, A Division of...
Orthopedic · 18d
Cleared Dec 10, 2001
Z-NET
K001003 · FMW
Demite Limited
General Hospital · 621d
Cleared Dec 10, 2001
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
K011244 · LKJ
Zeus Scientific, Inc.
Immunology · 231d