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
43081–43104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2012
CERNER FETALINK+(VERSION1.0)
K121758 · HGM
Cerner Corp.
Obstetrics & Gynecology · 116d
Cleared Oct 09, 2012
BRIGHTGLASS BRIGHTGLASS M
K122025 · EBG
Ktk Medical Supplies GmbH
Dental · 90d
Cleared Oct 09, 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
K122031 · HWC
Nextremity Solutions, LLC
Orthopedic · 90d
Cleared Oct 09, 2012
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY...
K122531 · JOH
Covidien
Anesthesiology · 50d
Cleared Oct 09, 2012
REMSTAR SE
K122769 · BZD
Respironics, Inc.
Anesthesiology · 29d
Cleared Oct 09, 2012
CROSS-OVER ACETABULAR SHELL & LINER
K122773 · OQG
Stelkast Company
Orthopedic · 29d
Cleared Oct 09, 2012
AXCESS SOFT TIP WIRE GUIDE
K122816 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 25d
Cleared Oct 09, 2012
RADREX-I, SW V4.00 MODEL DRAD-3000E
K122842 · MQB
Toshiba America Medical Systems, In.C
Radiology · 22d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · MEH
Smith & Nephew, Inc.
Orthopedic · 359d
Cleared Oct 05, 2012
EPOC CHLORIDE TEST AND EPOC CREATININE TEST
K113726 · CGL
Epocal, Inc.
Chemistry · 291d
Cleared Oct 05, 2012
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 274d
Cleared Oct 05, 2012
BTL ELITE
K120093 · IMJ
BTL Industries, Inc.
Physical Medicine · 267d
Cleared Oct 05, 2012
ALAMO T
K120401 · MAX
Alliance Partners, LLC
Orthopedic · 240d
Cleared Oct 05, 2012
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
K120499 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 227d
Cleared Oct 05, 2012
CORIN TRIFIT TS HIP
K121563 · MEH
Corin USA
Orthopedic · 129d
Cleared Oct 05, 2012
SIMPLE T NASAL MASK
K121631 · BZD
Respironics, Inc.
Anesthesiology · 123d
Cleared Oct 05, 2012
CVUE ADVANCED HYDRA VUE
K121652 · LPL
Unilens Corp., USA
Ophthalmic · 122d
Cleared Oct 05, 2012
TBS INSIGHT
K121716 · KGI
Medimaps Group SA
Radiology · 116d
Cleared Oct 05, 2012
TIGER SPINE SYSTEM
K121728 · NKB
Corelink, LLC
Orthopedic · 115d
Cleared Oct 05, 2012
BENCOX II STEM, BENCOX METAL HEAD
K122099 · LPH
Corentec Co., Ltd.
Orthopedic · 81d
Cleared Oct 05, 2012
DFP4343C7
K122589 · KPR
Mdi Consultants, Inc.
Radiology · 42d
Cleared Oct 05, 2012
PORTA 100HF
K122697 · IZL
Job Corporation
Radiology · 31d
Cleared Oct 05, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K122757 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 28d
Cleared Oct 05, 2012
MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K122843 · LLZ
Prodigy Technology Consultant Co., Ltd.
Radiology · 18d