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
46393–46416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2011
THE ESPINER SAC OR E SAC
K111845 · GCJ
Espiner Medical Limited
General & Plastic Surgery · 89d
Cleared Sep 26, 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · MAX
Spineology, Inc.
Orthopedic · 87d
Cleared Sep 26, 2011
TEPHAFLEX MESH
K111946 · OOD
Tepha, Inc.
General & Plastic Surgery · 80d
Cleared Sep 26, 2011
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K112232 · NLH
Stryker Sustainability Solutions
Cardiovascular · 53d
Cleared Sep 26, 2011
SELECTRA SLITTER TOOL
K112482 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2011
HAIRMAX LASERCOMB
K112524 · OAP
Lexington International, LLC
General & Plastic Surgery · 26d
Cleared Sep 23, 2011
ACQPOINT THERMAJADE MASSAGE TABLE
K102938 · JFB
Acqpoint, Inc.
Physical Medicine · 354d
Cleared Sep 23, 2011
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
K103150 · OXZ
Kimberly-Clark
General Hospital · 332d
Cleared Sep 23, 2011
MAMMODIAGNOST DR
K110572 · MUE
Philips Medical Systems
Radiology · 206d
Cleared Sep 23, 2011
RHYTHMVIEW (TM)
K110878 · DQK
Topera, Inc.
Cardiovascular · 177d
Cleared Sep 23, 2011
ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
K110913 · OCL
Endoscopic Technologies, Inc. D/B/A...
Cardiovascular · 175d
Cleared Sep 23, 2011
PLANMED NUANCE EXCEL
K111361 · MUE
Planmeca USA, Inc.
Radiology · 130d
Cleared Sep 23, 2011
CORELEADER COLLA-ALGI FIBER MODEL CAW
K111578 · FRO
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 108d
Cleared Sep 23, 2011
CS 7600
K111649 · MUH
Carestream Health, Inc.
Radiology · 102d
Cleared Sep 23, 2011
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
K111791 · IYX
Gamma Medica-Ideas Incorporated
Radiology · 88d
Cleared Sep 23, 2011
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
K111888 · DQA
Masimo Corporation
Anesthesiology · 84d
Cleared Sep 23, 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE...
K112071 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 65d
Cleared Sep 23, 2011
VENUE 40
K112122 · IYN
Ge Healthcare
Radiology · 60d
Cleared Sep 23, 2011
UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
K112463 · LZO
United Orthopedic Corporation
Orthopedic · 28d
Cleared Sep 23, 2011
CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
K112474 · KPS
Cedars-Sinai Medical Center
Radiology · 28d
Cleared Sep 23, 2011
ULTRASEAL XT HYDRO
K112517 · EBC
Ultradent Products, Inc.
Dental · 23d
Cleared Sep 22, 2011
SENSITITRE OPTIREAD
K110583 · LRG
Trek Diagnostic Systems, Ltd.
Microbiology · 205d
Cleared Sep 22, 2011
OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
K111069 · MNF
Osteosymbionics, LLC
General & Plastic Surgery · 157d
Cleared Sep 22, 2011
CORELEADER SCAR-DIMMER
K111733 · MDA
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 93d