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
81937–81960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2000
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
K002213 · FMI
Hunter Research Laboratories, Inc.
General Hospital · 74d
Cleared Oct 03, 2000
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
K002490 · LNH
Fonar Corp.
Radiology · 50d
Cleared Oct 03, 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K002568 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 46d
Cleared Oct 03, 2000
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
K002836 · MQL
Sage Biopharma
Obstetrics & Gynecology · 21d
Cleared Oct 02, 2000
TORNIER TOTAL ELBOW PROSTHESIS
K000003 · JDC
Tornier
Orthopedic · 273d
Cleared Oct 02, 2000
DISPOSABLE H-PE MICROKERATOME BLADES
K001464 · HNO
Oasis
Ophthalmic · 145d
Cleared Oct 02, 2000
GLUCANPRO CREAM
K002077 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 84d
Cleared Oct 02, 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 84d
Cleared Oct 02, 2000
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
K002294 · CDZ
Biocheck, Inc.
Chemistry · 67d
Cleared Oct 02, 2000
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
K002296 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 66d
Cleared Oct 02, 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · HRX
Endius, Inc.
Orthopedic · 54d
Cleared Oct 02, 2000
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · HAW
Stryker Corp.
Neurology · 31d
Cleared Sep 29, 2000
OLYMPIC WARM-UP
K001056 · ILY
Olympic Medical Corp.
Physical Medicine · 179d
Cleared Sep 29, 2000
OMNIPORT
K002013 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 88d
Cleared Sep 29, 2000
BRAVO PH MONITORING SYSTEM
K002028 · FFT
Endonetics, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 29, 2000
MODIFICATION TO: PRONTO DRY
K002451 · LYR
Medical Instruments Corporation, AG
Microbiology · 51d
Cleared Sep 29, 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS...
K002710 · HRS
Synthes (Usa)
Orthopedic · 29d
Cleared Sep 29, 2000
BAYER IMMUNO 1 HER-2/NEU ASSAY
K992228 · NCW
Bayer Corp.
Immunology · 455d
Cleared Sep 29, 2000
BIOSYS FETAL MONITOR, MODEL IFM-500
K994008 · HGM
Biosys Co. , Ltd.
Obstetrics & Gynecology · 310d
Cleared Sep 29, 2000
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
K994112 · NCW
Oncogene Science, Inc.
Immunology · 298d
Cleared Sep 28, 2000
PREFERENCE TREATMENT SYSTEM
K001833 · IYE
Northwest Medical Physics Equipment,...
Radiology · 104d
Cleared Sep 28, 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 73d
Cleared Sep 28, 2000
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215 · MOB
Cogent Diagnotics , Ltd.
Immunology · 66d
Cleared Sep 28, 2000
COMFORT CONTROL SYRINGE SYSTEM
K002387 · EJI
Dentsply Intl.
Dental · 55d