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
67537–67560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2004
ASCENSION PYROSPHERE (PCS)
K042690 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 45d
Cleared Nov 12, 2004
TOE MP JOINT, MODELS 10412-10414, 14958, 14960,...
K041595 · KWD
Biopro, Inc.
Orthopedic · 151d
Cleared Nov 12, 2004
GENICON SUCTION IRRIGATION SYSTEM
K041967 · GCJ
Genicon
General & Plastic Surgery · 114d
Cleared Nov 12, 2004
NICOM
K042144 · DXG
Cheetah Medical, Inc.
Cardiovascular · 95d
Cleared Nov 12, 2004
COOL-TIP RF ABLATION SYSTEM
K042216 · GEI
Valleylab
General & Plastic Surgery · 88d
Cleared Nov 12, 2004
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
K042231 · HCG
Biocompatibles UK Limited
Neurology · 87d
Cleared Nov 12, 2004
SENSATOUCH
K042250 · IYO
Aluna Management Co., Ltd.
Radiology · 84d
Cleared Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
K042291 · CEM
Beckman Coulter, Inc.
Chemistry · 80d
Cleared Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · DQX
Cook, Inc.
Cardiovascular · 49d
Cleared Nov 12, 2004
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
K042718 · MOS
Siemens Medi Cal Solutions, Inc.
Radiology · 43d
Cleared Nov 12, 2004
GENEMAX POWER WHEELCHAIR, PW3
K042748 · ITI
Genemax Medical Products Industry Corp.
Physical Medicine · 39d
Cleared Nov 12, 2004
GENEMAX POWER WHEELCHAIR, PW4
K042749 · ITI
Genemax Medical Products Industry Corp.
Physical Medicine · 39d
Cleared Nov 12, 2004
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K042843 · BTM
Ambu, Inc.
Anesthesiology · 29d
Cleared Nov 12, 2004
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT...
K042845 · MSX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Nov 12, 2004
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
K042855 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 28d
Cleared Nov 12, 2004
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
K042908 · NTE
Guidant Corp.
Cardiovascular · 22d
Cleared Nov 12, 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
K042909 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 22d
Cleared Nov 12, 2004
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042914 · MBI
Opus Medical, Inc.
Orthopedic · 22d
Cleared Nov 10, 2004
ORAJEL ADVANCED TOOTH DESENSITIZER
K041680 · KLE
Del Pharmaceuticals, Inc.
Dental · 142d
Cleared Nov 10, 2004
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
K041818 · ITX
Boston Scientific Corp
Radiology · 127d
Cleared Nov 10, 2004
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
K041855 · MSH
Aearo Co.
General Hospital · 124d
Cleared Nov 10, 2004
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
K041903 · FDF
Fujinon, Inc.
Gastroenterology & Urology · 119d
Cleared Nov 10, 2004
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218,...
K042171 · EGS
Micro-Mega Societe Anonyme
Dental · 91d
Cleared Nov 10, 2004
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM
K042188 · IYO
Volcano Therapeutics, Inc.
Radiology · 90d