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

Filters: Cleared only ×
175,820 results
35833–35856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2015
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K143131 · LZA
Kossan International Sdn Bhd
General Hospital · 104d
Cleared Feb 12, 2015
Vanguard 360 Revision Knee System
K143192 · JWH
Biomet, Inc.
Orthopedic · 98d
Cleared Feb 12, 2015
Visionaire Disposable Instruments
K143226 · JWH
Smith & Nephew, Inc.
Orthopedic · 94d
Cleared Feb 12, 2015
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical...
K143297 · MAX
Zimmer Spine, Inc.
Orthopedic · 87d
Cleared CT Feb 12, 2015
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert...
K143302 · PEU
Cepheid
Microbiology · 87d
Cleared Feb 12, 2015
PedFuse Pedicle Screw System
K143377 · MNH
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Feb 12, 2015
SOFTECH Plus ETCO2 Cannula
K143469 · CCK
Teleflexmedical, Inc.
Anesthesiology · 69d
Cleared Feb 12, 2015
CD HORIZON Spinal System
K143569 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 58d
Cleared Feb 12, 2015
Navigated Vertex Select Instruments
K143628 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Feb 11, 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
K142685 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 142d
Cleared Feb 11, 2015
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
K142987 · EIH
Dental Direkt of Amerika UG...
Dental · 118d
Cleared Feb 11, 2015
Tensyn Plug
K143092 · HTN
Dallen Medical, Inc.
Orthopedic · 106d
Cleared Feb 11, 2015
CD HORIZON SPINAL SYSTEM
K150178 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Feb 10, 2015
TI NASAL MASK
K140980 · BZD
Respironics, Inc.
Anesthesiology · 300d
Cleared Feb 10, 2015
BIOS KING BIOCELLULOSE FILM
K141382 · FRO
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 259d
Cleared Feb 10, 2015
OPTIMUS NEURO SYSTEM
K141911 · GWO
Osteonic Co., Ltd.
Neurology · 210d
Cleared Feb 10, 2015
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
K142472 · IYN
Ge Healthcare
Radiology · 160d
Cleared Feb 10, 2015
VCARE
K142716 · LKF
Conmed Corporation
Obstetrics & Gynecology · 140d
Cleared Feb 10, 2015
G7 Freedom and Offset Liners, Freedom Head, Size 32
K142882 · LPH
Biomet, Inc.
Orthopedic · 131d
Cleared Feb 10, 2015
PASS LP Spinal System
K150049 · MNI
Medicrea International
Orthopedic · 29d
Cleared Feb 10, 2015
MICRONAIL Distal Radius System
K150073 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Feb 10, 2015
STERISPINE PS Pedicle Screw
K150092 · NKB
Safe Orthopaedics
Orthopedic · 25d
Cleared Feb 09, 2015
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
K140949 · MEG
Ultimed Incorporated
General Hospital · 301d
Cleared Feb 09, 2015
PMMA BLOCK
K141421 · EBG
Rizhao Huge Dental Industry Co., Ltd.
Dental · 255d