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
75577–75600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2002
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
K022119 · EFB
Electro Medical Systems SA
Dental · 24d
Cleared Jul 25, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
K022129 · LON
Becton, Dickinson & CO
Microbiology · 24d
Cleared Jul 25, 2002
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
K022169 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 25, 2002
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
K022225 · HSB
Vector Medical, Inc.
Orthopedic · 15d
Cleared Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · HRS
Synthes (Usa)
Orthopedic · 13d
Cleared Jul 24, 2002
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
K020004 · BZG
Compleware Corp.
Anesthesiology · 203d
Cleared Jul 24, 2002
PRISMAFLO
K020103 · KOC
Stihler Electronic GmbH
Gastroenterology & Urology · 194d
Cleared Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · LTK
Bayer Corp.
Immunology · 132d
Cleared Jul 24, 2002
ENDOSSOUS IMPLANTS
K021322 · DZE
Intra-Lock International
Dental · 90d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376 · DSI
Datex-Ohmeda
Cardiovascular · 84d
Cleared Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · HRS
Synthes (Usa)
Orthopedic · 78d
Cleared Jul 24, 2002
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466 · LPH
Hayes Medical, Inc.
Orthopedic · 78d
Cleared Jul 24, 2002
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Jul 24, 2002
ABP FOR WINDOWS
K021517 · DSK
Rozinn Electronics, Inc.
Cardiovascular · 75d
Cleared Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 62d
Cleared Jul 24, 2002
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE...
K021784 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 55d
Cleared Jul 24, 2002
HEARTLINE RECEIVING STATION
K022073 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 28d
Cleared Jul 24, 2002
MPF ACETABULAR CUP GENERATION 2
K022120 · LZO
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 24, 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · MNI
Depuyacromed
Orthopedic · 19d
Cleared Jul 23, 2002
CRIT-LINE MONITOR III TQA (CLM TQA)
K011741 · FIL
Hemametrics
Gastroenterology & Urology · 413d
Cleared Jul 23, 2002
INFINITY MICRO2+
K012770 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 340d
Cleared Jul 23, 2002
PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
K012974 · FLL
Prizm Medical, Inc.
General Hospital · 321d
Cleared Jul 23, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020356 · MNH
Alphatec Mfg., Inc.
Orthopedic · 169d
Cleared Jul 23, 2002
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
K020474 · MSH
Makrite Industries, Inc.
General Hospital · 161d