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
41065–41088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL...
K120945 · CKA
Hitachi Chemical Diagnostics, Inc.
Chemistry · 435d
Cleared Jun 07, 2013
XGEO GU60
K123105 · KPR
Samsung Electronics Co., Ltd.
Radiology · 248d
Cleared Jun 07, 2013
IMR SOFTWARE APPLICATION
K123576 · JAK
Philips Healthcare (Cleveland)
Radiology · 199d
Cleared Jun 07, 2013
DIAZYME MYOGLOBIN
K123785 · DDR
Diazyme Laboratories
Chemistry · 179d
Cleared Jun 07, 2013
4WEB OSTEOTOMY BONE WEDGE
K130185 · HRS
4-Web, Inc.
Orthopedic · 133d
Cleared Jun 07, 2013
BEARING NSPVA EMBOLIZATION PARTICLES
K130259 · NAJ
Merit Medical Systems, Inc.
Obstetrics & Gynecology · 126d
Cleared Jun 07, 2013
FASTBRACES CERAMIC BRACKETS
K130446 · NJM
Orthodontic Design and Production, Inc.
Dental · 106d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · MQB
Carestream Health, Inc.
Radiology · 105d
Cleared Jun 07, 2013
TELERADPRO EDGE
K130636 · LMA
Vidar Systems Corp.
Radiology · 88d
Cleared Jun 07, 2013
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
K130726 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 81d
Cleared Jun 07, 2013
PRELUDE SHEATH INTRODUCER
K130791 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 77d
Cleared Jun 07, 2013
ISR'OBOT MONA LISA
K130944 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Jun 07, 2013
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
K131051 · JGQ
Hitachi Chemical Diagnostics, Inc.
Chemistry · 53d
Cleared Jun 07, 2013
LIMACORPORATE SMR CTA HUMERAL HEADS
K131112 · KWS
Lima Corporate S.P.A.
Orthopedic · 46d
Cleared Jun 07, 2013
ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
K131115 · GCJ
Nds Surgical Imaging
General & Plastic Surgery · 49d
Cleared Jun 07, 2013
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
K131217 · CIG
Hitachi Chemical Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 07, 2013
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K131300 · DYB
Access Scientific, LLC
Cardiovascular · 31d
Cleared Jun 06, 2013
CRITICAL CARE VENTILATOR
K120931 · CBK
Oricare, Inc.
Anesthesiology · 436d
Cleared Jun 06, 2013
DAS MEDICAL EQUIPMENT DRAPES
K121436 · KKX
Das Medical, LLC
General Hospital · 387d
Cleared Jun 06, 2013
WIZARD 230 NASAL PILOW MASK
K121642 · BZD
Apex Medical Corp.
Anesthesiology · 367d
Cleared Jun 06, 2013
NATRATONE
K121902 · HIR
Orelle Corporation, Ltd.
Gastroenterology & Urology · 342d
Cleared Jun 06, 2013
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
K123394 · FRO
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 216d
Cleared Jun 06, 2013
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
K123481 · FRO
Convatec, Inc.
General & Plastic Surgery · 205d
Cleared Jun 06, 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · LPH
United Orthopedic Corporation
Orthopedic · 135d