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
36049–36072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2015
Arthrex Fracture System
K143139 · HRS
Arthrex, Inc.
Orthopedic · 74d
Cleared Jan 16, 2015
Medline ReNewal Reprocessed Compression Limb Sleeves
K143166 · JOW
Surgical Instrument Service and...
Cardiovascular · 73d
Cleared Jan 16, 2015
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
K143190 · MVN
Yung Sheng Optical Co., Ltd.
Ophthalmic · 72d
Cleared Jan 16, 2015
Ultrasound Scanner System bk2300
K143298 · IYN
Bk Medical Aps
Radiology · 60d
Cleared Jan 16, 2015
Audit MicroControls Linearity FD Tumor Markers II
K143573 · JJY
Aalto Scientific, Ltd.
Immunology · 30d
Cleared Jan 16, 2015
GEM Flow COUPLER Device and System
K143589 · MVR
Synovis Life Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Jan 16, 2015
Arthrex Low Profile Screws
K143614 · HWC
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 15, 2015
NEONATALIE RESUSCITATOR
K132172 · BTM
Laerdal Medical A/S
Anesthesiology · 549d
Cleared Jan 15, 2015
PRO X OTC 5
K140471 · OHS
La Lumiere, LLC
General & Plastic Surgery · 324d
Cleared Jan 15, 2015
GENASIS HIPATH IHC FAMILY
K140957 · NQN
Applied Spectral Imaging , Ltd.
Pathology · 276d
Cleared Jan 15, 2015
SUPER SHEATH
K141070 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 265d
Cleared Jan 15, 2015
IMPIX ALIF S/A
K141187 · OVD
Medicrea International SA
Orthopedic · 252d
Cleared Jan 15, 2015
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K141224 · LYZ
Shijiazhunag Jiuyuan Plastic Co., Ltd.
General Hospital · 248d
Cleared Jan 15, 2015
SImmetry Sacroiliac Joint Fusion System
K141549 · OUR
Zyga Technology, Inc.
Orthopedic · 218d
Cleared Jan 15, 2015
DISPOSABLE INJECTION NEEDLE
K142144 · FBK
Wilson Instruments (Shanghai) Company...
Gastroenterology & Urology · 163d
Cleared Jan 15, 2015
EVS 4343
K142475 · MQB
DRTECH Corporation
Radiology · 134d
Cleared Jan 15, 2015
IV Administration
K142622 · FPA
Hospira, Inc.
General Hospital · 121d
Cleared Jan 15, 2015
CI../..X liner for NOVAE Dual Mobility Acetabular Cup
K142675 · LZO
Serf
Orthopedic · 118d
Cleared Jan 15, 2015
Powder-free PVC Vinyl Exam Gloves
K142703 · LYZ
Hebei Grandeast Plastic Products Co.,...
General Hospital · 115d
Cleared Jan 15, 2015
OASYS System
K142741 · KWP
Stryker Corporation
Orthopedic · 113d
Cleared Jan 15, 2015
osteoSPAN Morpheus
K142828 · MQV
Biogennix
Orthopedic · 107d
Cleared Jan 15, 2015
CareEvent
K142935 · MSX
Philips Medical Systems
Cardiovascular · 98d
Cleared CT Jan 15, 2015
Erchonia Zerona Z6 OTC
K143007 · OLI
Erchonia Corporation
General & Plastic Surgery · 87d
Cleared Jan 15, 2015
Exilis XP
K143040 · PBX
BTL Industries, Inc.
General & Plastic Surgery · 85d