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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62137–62160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2006
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · NEY
Guidant Corp.
General & Plastic Surgery · 24d
Cleared Jul 27, 2006
SYNGO MULTIMODALITY WORKPLACE
K061964 · LLZ
Siemens AG Medical Solutions
Radiology · 15d
Cleared Jul 26, 2006
TSO3 OZONE STERILIZER, MODEL 125L
K051595 · FLF
Tso3, Inc.
General Hospital · 405d
Cleared Jul 26, 2006
TRULENE MESH
K060018 · FTL
Sutures India Pvt., Ltd.
General & Plastic Surgery · 203d
Cleared Jul 26, 2006
FSSB NYLON SURGICAL SUTURES
K060471 · GAR
Fssb Chirurgische Nadeln GmbH
General & Plastic Surgery · 153d
Cleared Jul 26, 2006
VYCOR SURGICAL ACCESS SYSTEMS
K060973 · GZT
Vycor Medical, LLC
Neurology · 107d
Cleared Jul 26, 2006
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
K061162 · MNH
Applied Spine Technologies, Inc.
Orthopedic · 91d
Cleared Jul 26, 2006
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
K061285 · FPA
Cardinal Health, Alaris Products
General Hospital · 79d
Cleared Jul 26, 2006
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K061476 · GZJ
Biomedical Life Systems, Inc.
Neurology · 57d
Cleared Jul 26, 2006
ALTES BUTTRESS PLATING SYSTEM
K061482 · KWQ
Altiva Corp.
Orthopedic · 57d
Cleared Jul 26, 2006
FLEXO DENTAL RESIN MATERIAL
K061501 · EBI
Aci, Inc.
Dental · 56d
Cleared Jul 26, 2006
PIN SCREW
K061599 · JDW
Bk Meditech, Co., Ltd.
Orthopedic · 48d
Cleared Jul 26, 2006
IFS CANNULATED BONE SCREW
K061620 · HWC
Internal Fixation Systems, Inc.
Orthopedic · 47d
Cleared Jul 26, 2006
INSORB ABSORBABLE STAPLE, MODEL 1020
K061784 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Jul 25, 2006
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
K053446 · MKZ
Gen-Probe, Inc.
Microbiology · 225d
Cleared Jul 25, 2006
FITPACK
K060037 · MMK
Asp Plastics Pty , Ltd.
General Hospital · 200d
Cleared Jul 25, 2006
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST
K060527 · DJG
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared Jul 25, 2006
XPERT, GENEXPERT DX SYSTEM
K060540 · NJR
Cepheid
Microbiology · 146d
Cleared Jul 25, 2006
HYDROMARK BIOPSY SITE MARKER
K060769 · NEU
Biopsy Sciences, LLC
General & Plastic Surgery · 125d
Cleared Jul 25, 2006
ELEMENT BLOOD GLUCOSE TEST SYSTEM
K060793 · NBW
Home Diagnostics, Inc.
Chemistry · 124d
Cleared Jul 25, 2006
BRAINPRO, BRAINPRO ACCESS
K060808 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 123d
Cleared Jul 25, 2006
PULSION PICCO PLUS, MODEL 8100
K060898 · DXG
Pulsion Medical Systems AG
Cardiovascular · 113d
Cleared Jul 25, 2006
ORAL BALANCE LIQUID/ GEL
K061331 · LFD
Laclede, Inc.
Dental · 74d
Cleared Jul 25, 2006
APNEALINK, MODEL 22302
K061405 · MNR
Resmed Germany, Inc.
Anesthesiology · 67d