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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49033–49056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 50d
Cleared Nov 17, 2010
MOUNTAINEER OCT SPINAL SYSTEM
K103100 · MNI
Depuy Spine, Inc.
Orthopedic · 28d
Cleared Nov 16, 2010
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL...
K100565 · MKJ
Bio-Detek, Inc.
Cardiovascular · 260d
Cleared Nov 16, 2010
MINIATURIZE CHEST COMPRESSOR (MCC)
K102068 · DRM
Resuscitation International
Cardiovascular · 116d
Cleared Nov 16, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102171 · LYZ
Wuxi Bingfa Gainlite Gloves Cp., Ltd.
General Hospital · 106d
Cleared Nov 16, 2010
PTFE PORTABLE INTRODUCER
K102540 · DYB
Great Batch Medical
Cardiovascular · 74d
Cleared Nov 16, 2010
LAPAROSCOPIC DISSECTOR
K103282 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 11d
Cleared Nov 15, 2010
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · GZT
KARL STORZ Endoscopy-America, Inc.
Neurology · 411d
Cleared Nov 15, 2010
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K100888 · KWP
Lanx, Inc.
Orthopedic · 230d
Cleared Nov 15, 2010
VIPER F2 FACET FIXATION SYSTEM
K101762 · MRW
Depuy Spine, Inc.
Orthopedic · 146d
Cleared Nov 15, 2010
CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
K102204 · NKB
Choicespine, LP
Orthopedic · 102d
Cleared Nov 15, 2010
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
K102326 · HWC
Parcus Medical, LLC
Orthopedic · 90d
Cleared Nov 15, 2010
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
K103215 · JAQ
Cianna Medical
Radiology · 14d
Cleared CT Nov 12, 2010
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS...
K101174 · OCL
AtriCure, Inc.
Cardiovascular · 199d
Cleared Nov 12, 2010
CONSTELLATION VISION SYSTEM
K101285 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 189d
Cleared Nov 12, 2010
WELCH ALLYN 1500 PATIENT MONITOR
K101619 · MHX
Schiller AG
Cardiovascular · 156d
Cleared Nov 12, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
K102558 · LYZ
Tangshan Hengda Plastic Products Co.,...
General Hospital · 66d
Cleared Nov 12, 2010
VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
K102626 · JCX
Vega Technologies, Inc.
General & Plastic Surgery · 60d
Cleared Nov 10, 2010
BIOSIGN FLU A+B
K083746 · PSZ
Princeton BioMeditech Corp.
Microbiology · 693d
Cleared Nov 10, 2010
DIO STEADY EXTERNAL IMPLANT SYSTEM
K100100 · DZE
Dio Corporation
Dental · 302d
Cleared Nov 10, 2010
EDGE CO2 LASER SYSTEM
K100590 · ONG
Jm System Co., Ltd.
General & Plastic Surgery · 253d
Cleared Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 233d
Cleared Nov 10, 2010
POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
K101105 · LYY
Best Putra Gloves Sdn Bhd
General Hospital · 204d
Cleared Nov 10, 2010
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
K101106 · LYY
Best Putra Gloves Sdn Bhd
General Hospital · 204d