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
79129–79152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2001
CANNULATED PLUS SCREW SYSTEM
K010738 · HWC
Orthomatrix, Inc.
Orthopedic · 142d
Cleared Aug 01, 2001
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908 · HCH
Medicon EG
Neurology · 128d
Cleared Aug 01, 2001
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · HCI
Medicon EG
Neurology · 128d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 99d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · GAM
Aesculap, Inc.
General & Plastic Surgery · 89d
Cleared Aug 01, 2001
ARTHREX BIO-POST AND WASHER
K011495 · MAI
Arthrex, Inc.
Orthopedic · 78d
Cleared Aug 01, 2001
ORTHO VLC
K011521 · DYH
First Scientific Limited
Dental · 76d
Cleared Aug 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
K011791 · LZA
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K011792 · LZA
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · FGE
Cordis Europa, N.V.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
8100/8500 VITAL SIGNS MONITOR
K012059 · MWI
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Aug 01, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012066 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
K012069 · JXE
Neurotron Medical, Inc.
Neurology · 30d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012090 · FGE
Cordis, A Johnson & Johnson Co.
Gastroenterology & Urology · 27d
Cleared Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128 · FOZ
Ethicon Endo-Surgery, Inc.
General Hospital · 23d
Cleared Aug 01, 2001
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K012135 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 23d
Cleared Aug 01, 2001
MODIFICATION TO: LONG LENGTH GAMMA NAIL
K012158 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 01, 2001
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
K012166 · LZA
Best Manufacturing Company
General Hospital · 21d
Cleared Aug 01, 2001
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
K012167 · IOR
Invacare Corp.
Physical Medicine · 20d
Cleared Aug 01, 2001
M5T INSTANT FEVER THERMOMETER
K012217 · FLL
Medisim, Ltd.
General Hospital · 16d
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 14d
Cleared Aug 01, 2001
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
K012281 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 12d
Cleared Aug 01, 2001
MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
K012299 · DZE
Basic Dental Implant Systems, Inc.
Dental · 12d