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
77593–77616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2002
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
K011238 · LZF
Metracor Technologies, Inc.
General Hospital · 260d
Cleared Jan 08, 2002
SABRE COMPAC
K011842 · GWJ
Sle Limited
Neurology · 210d
Cleared Jan 08, 2002
WAMPOLE HS-CRP ELISA
K011855 · DCN
Carter-Wallace, Inc.
Chemistry · 209d
Cleared Jan 08, 2002
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
K011876 · HIG
Circon Video
Obstetrics & Gynecology · 207d
Cleared Jan 08, 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · MMI
Biocheck, Inc.
Chemistry · 118d
Cleared Jan 08, 2002
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE...
K013365 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 90d
Cleared Jan 08, 2002
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
K013366 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 90d
Cleared Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387 · MSX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Jan 08, 2002
LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
K013421 · BZD
Lifeguard Medical Products, Inc.
Anesthesiology · 84d
Cleared Jan 08, 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013589 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 70d
Cleared Jan 08, 2002
EXTREMITY COIL
K013592 · MOS
Usa Instruments, Inc.
Radiology · 70d
Cleared Jan 08, 2002
VIABAHN ENDOPROSTHESIS
K013648 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 64d
Cleared Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared Jan 08, 2002
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM...
K013695 · GCJ
Microline Pentax, Inc.
General & Plastic Surgery · 62d
Cleared Jan 08, 2002
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH...
K013718 · OTO
Gynecare, A Div. of Ethicon, Inc.
Obstetrics & Gynecology · 61d
Cleared Jan 08, 2002
BICART
K013724 · KPO
Gambro Renal Products
Gastroenterology & Urology · 60d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · LDP
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Jan 08, 2002
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
K013775 · HRS
Stryker Leibinger
Orthopedic · 56d
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · MSV
Diamedix Corp.
Immunology · 39d
Cleared Jan 08, 2002
BOEHRINGER MRI SUCTION REGULATORY
K013976 · KDP
Boehringer Laboratories
General Hospital · 36d
Cleared Jan 08, 2002
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
K014078 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 28d
Cleared Jan 08, 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · DTZ
Dideco S.P.A.
Cardiovascular · 28d
Cleared Jan 08, 2002
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083 · CAC
Haemonetics Corp.
Anesthesiology · 28d
Cleared Jan 08, 2002
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
K014100 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 26d