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
82657–82680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7,...
K001063 · DYG
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared Jul 07, 2000
PANORET, MODEL 1000A
K001111 · HKL
Cmt Medical Technologies, Ltd.
Ophthalmic · 92d
Cleared Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
K001143 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 88d
Cleared Jul 07, 2000
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD...
K001156 · KDI
Gambro Renal Products
Gastroenterology & Urology · 88d
Cleared Jul 07, 2000
ULTRA V THERAPEUTIC ULTRASOUND
K001166 · IMG
Excel Tech. , Ltd.
Physical Medicine · 88d
Cleared Jul 07, 2000
OPI BAND
K001167 · MVA
Orthomerica Products, Inc.
Neurology · 88d
Cleared Jul 07, 2000
EXTERNAL FIXATION ANCHOR PIN
K001228 · JDW
Immedica, Inc.
Orthopedic · 81d
Cleared Jul 07, 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · DQX
Nipro Medical Corp.
Cardiovascular · 79d
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
CARDEON ASCENDING BALLOON CANNULA (ABC)
K001371 · DWF
Cardeon Corp.
Cardiovascular · 67d
Cleared Jul 07, 2000
MODIFICATION TO PROMPT L-POP
K001494 · KLE
Espe Dental AG
Dental · 56d
Cleared Jul 07, 2000
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD
Diamedix Corp.
Microbiology · 32d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 07, 2000
THE V-BAG
K001822 · DTN
Circulatory Technology, Inc.
Cardiovascular · 21d
Cleared Jul 07, 2000
IM-9C MICROINJECTORS
K001910 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
IM-9A MICROINJECTORS
K001911 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
IM-9B MICROINJECTORS
K001912 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032 · DXZ
Bridger Biomed, Inc.
Cardiovascular · 224d
Cleared Jul 06, 2000
PROLONG, MODELS PL50, PL100, PL150
K001129 · CAZ
Life-Tech Intl., Inc.
Anesthesiology · 90d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jul 06, 2000
LIFERX
K001596 · LLZ
Bowdengs Technologies, LLC
Radiology · 44d
Cleared Jul 06, 2000
LUNAR REPORT GENERATOR II
K001756 · KGI
Lunar Corp.
Radiology · 27d
Cleared Jul 06, 2000
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
K001772 · HQF
Taracan Pty. , Ltd.
Ophthalmic · 24d
Cleared Jul 06, 2000
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K001789 · OXD
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 23d