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
82009–82032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2000
MMN-1 COARSE MANIPULATOR
K002653 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 28d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · HWC
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 22, 2000
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
K002658 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 28d
Cleared Sep 22, 2000
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
K002659 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 28d
Cleared Sep 21, 2000
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
K000825 · DQO
Medi-Dyne, Inc.
Cardiovascular · 191d
Cleared Sep 21, 2000
DISPOSABLE MICROKERATOME BLADES-PE
K001176 · HNO
Oasis Medical, Inc.
Ophthalmic · 163d
Cleared Sep 21, 2000
ZYBIT
K002004 · DXH
Zymed Medical Instrumentation
Cardiovascular · 80d
Cleared Sep 21, 2000
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
K002029 · DXN
Zoll Medical Corp
Cardiovascular · 80d
Cleared Sep 21, 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · DXN
Critikon Company, LLC
Cardiovascular · 58d
Cleared Sep 21, 2000
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041,...
K002599 · FRO
Acrymed, Inc.
General & Plastic Surgery · 31d
Cleared Sep 21, 2000
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 6d
Cleared Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465 · JXG
Sophysa SA
Neurology · 426d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · DXG
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Sep 20, 2000
MICOR CONDUCTION CATHETER
K001717 · BSO
Micor, Inc.
Anesthesiology · 107d
Cleared Sep 20, 2000
POLESTAR N-10
K002242 · LNH
Odin Technologies , Ltd.
Radiology · 58d
Cleared Sep 20, 2000
ALOKA UST-5280-5
K002784 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Sep 20, 2000
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
K994340 · HLI
Hai Laboratories, Inc.
Ophthalmic · 272d
Cleared Sep 19, 2000
BUFFLIGHT CLT SURGICAL LASER SYSTEM
K000727 · GEX
Y-Beam Technologies, Inc.
General & Plastic Surgery · 197d
Cleared Sep 19, 2000
CANDELA SPTL-1B PULSED DYE LASER
K001093 · GEX
Candela Corp.
General & Plastic Surgery · 168d
Cleared Sep 19, 2000
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
K001366 · KXK
Prostec, LLC
Radiology · 172d
Cleared Sep 19, 2000
OCCU-FLO PUNCTUM PLUGS
K001768 · LZU
U.S. Iol, Inc.
Ophthalmic · 99d
Cleared Sep 19, 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 19, 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE...
K001901 · LJS
C.R. Bard, Inc.
General Hospital · 89d
Cleared Sep 19, 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 88d