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
43825–43848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2012
FLEXITIME MONOPHASE PRO SCAN
K113574 · ELW
Heraeus Kulzer, LLC
Dental · 224d
Cleared CT Jul 13, 2012
CRUX VENA CAVA FILTER SYSTEM
K120402 · DTK
Crux Biomedical
Cardiovascular · 156d
Cleared Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K120413 · OCC
Focus Diagnostics, Inc.
Microbiology · 154d
Cleared Jul 13, 2012
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER,...
K120481 · HEB
Tosama, D.O.O.
Obstetrics & Gynecology · 148d
Cleared Jul 13, 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
K120827 · NEW
Angiotech
General & Plastic Surgery · 116d
Cleared Jul 13, 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903 · HRS
Acumed, LLC
Orthopedic · 109d
Cleared Jul 13, 2012
CAPNOGRAPHY PAD (92516)
K121017 · CCK
Spacelabs Healthcare
Anesthesiology · 100d
Cleared Jul 13, 2012
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
K121161 · KPE
Acta Medical, LLC
General Hospital · 87d
Cleared Jul 13, 2012
RESIN 11
K121170 · BYI
Respinnovation Sas
Anesthesiology · 87d
Cleared Jul 13, 2012
INFILL INTERVERTEBRAL BODY FUSION DEVICE
K121733 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 30d
Cleared Jul 13, 2012
MANTARAY GUIDEWIRES
K121745 · DQX
Bridgepoint Medical
Cardiovascular · 29d
Cleared Jul 13, 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · OCL
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jul 12, 2012
CS1000 LIGHT THERAPY DEVICE
K110558 · ILY
Genesis Health Light Corporation
Physical Medicine · 500d
Cleared Jul 12, 2012
ARROW REVERSE SHOULDER SYSTEM
K112193 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 349d
Cleared Jul 12, 2012
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
K113436 · CJE
Alfa Wassermann
Chemistry · 234d
Cleared Jul 12, 2012
MYRIAN 1.11
K113620 · LLZ
Intrasense
Radiology · 218d
Cleared Jul 12, 2012
RENAISSANCE
K120812 · HAW
Mazor Robotics , Ltd.
Radiology · 118d
Cleared Jul 12, 2012
0.9% SODIUM CHLORIDE FLISH SYRINGE
K120836 · NGT
Am USA
General Hospital · 114d
Cleared Jul 12, 2012
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
K121113 · NEU
Biopsy Sciences, LLC
General & Plastic Surgery · 91d
Cleared Jul 12, 2012
BW685, BW685S
K121198 · LGZ
Biegler GmbH
General Hospital · 84d
Cleared Jul 12, 2012
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH...
K121306 · GAT
Arthocare Corporation
General & Plastic Surgery · 72d
Cleared Jul 12, 2012
PRESSON ELECTRODE
K121347 · GXZ
Rhythmlink International, LLC
Neurology · 72d
Cleared Jul 12, 2012
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
K121529 · LZA
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Jul 11, 2012
GYMFORM DUAL FLEX BELT MODEL WB-162
K111781 · NGX
Well Brain International , Ltd.
Physical Medicine · 383d