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
75745–75768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K021473 · DWJ
Augustine Medical, Inc.
Cardiovascular · 62d
Cleared Jul 09, 2002
CYPRESS ULTRASOUND SYSTEM
K021497 · IYN
Acuson Corp.
Radiology · 61d
Cleared Jul 09, 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 29d
Cleared Jul 09, 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
K021908 · JWH
Stelkast Company
Orthopedic · 29d
Cleared Jul 09, 2002
MICROPLEX COIL SYSTEMS (MCS)
K021914 · HCG
MicroVention, Inc.
Neurology · 28d
Cleared Jul 09, 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION...
K022050 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jul 08, 2002
S7 ELITE CP AP SYSTEM
K013909 · BZD
ResMed Corp
Anesthesiology · 224d
Cleared Jul 08, 2002
SURECAN SAFETY HUBER NEEDLE INFUSION SETS
K021488 · FPA
B.Braun Medical, Inc.
General Hospital · 61d
Cleared Jul 05, 2002
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 143d
Cleared Jul 05, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · LYY
Allegiance Healthcare Corp.
General Hospital · 114d
Cleared Jul 05, 2002
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE...
K021007 · LYY
Tillotson Healthcare Corp.
General Hospital · 99d
Cleared Jul 05, 2002
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING...
K021119 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 88d
Cleared Jul 05, 2002
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179 · OCY
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 81d
Cleared Jul 05, 2002
ULTRASONIC TIPS WITH DIAMOND COATING
K021253 · ELC
Sybron Endo/Analytic
Dental · 77d
Cleared Jul 05, 2002
EMBRYO BIOPSY MEDIUM
K021358 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 67d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · JFY
Bayer Corp.
Chemistry · 63d
Cleared Jul 05, 2002
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
K021730 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 42d
Cleared Jul 05, 2002
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018 · LJM
Rhigene, Inc.
Immunology · 15d
Cleared Jul 03, 2002
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
K002741 · JOJ
Albert Browne , Ltd.
General Hospital · 670d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
K012600 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
K012609 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
K012622 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
POWERED MUSCLE STIMULATOR
K013768 · IPF
Theratech, Inc.
Physical Medicine · 232d
Cleared Jul 03, 2002
FIBIOCORE
K020431 · ELR
Est. Anthogyr
Dental · 145d