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

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176,076 results
73633–73656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2003
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K023715 · LYY
Starmatrix Sdn Bhd
General Hospital · 91d
Cleared Feb 04, 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP...
K023828 · DCK
Kamiya Biomedical Co.
Immunology · 78d
Cleared Feb 04, 2003
AIROCIDE TI02
K023830 · FRA
Kes Science & Technology, Inc.
General Hospital · 78d
Cleared Feb 04, 2003
GE DISCOVERY LS SYSTEM
K023988 · KPS
GE Medical Systems
Radiology · 64d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042 · LNH
Philips Medical Systems, Inc.
Radiology · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Feb 04, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K024187 · MOS
Usa Instruments, Inc.
Radiology · 47d
Cleared Feb 04, 2003
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
K024188 · LMC
Sony Medical Systems
Radiology · 47d
Cleared Feb 03, 2003
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
K020318 · FRO
Scivolutions, Inc.
General & Plastic Surgery · 369d
Cleared Feb 03, 2003
RADIUS MICRO SNARE
K022201 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 213d
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · FRO
Coloplast Corp.
General & Plastic Surgery · 194d
Cleared Feb 03, 2003
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
K022483 · FRO
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 189d
Cleared Feb 03, 2003
WATERLASE FOR APICOECTOMY
K022803 · MXF
Biolase Technology, Inc.
Dental · 164d
Cleared Feb 03, 2003
REPROCESSED EXTERNAL FIXATION DEVICE
K023714 · KTT
Alliance Medical Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
K023724 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
K023725 · GDW
Marina Medical Instruments, Inc.
General & Plastic Surgery · 89d
Cleared Feb 03, 2003
SIASCOPE II
K023729 · PSN
Astron Clinica Limited
General & Plastic Surgery · 89d
Cleared Feb 03, 2003
POWDERED VINYL EXAMINATION GLOVES
K024016 · LYZ
Top Glove (Zhangjiagang) Co. , Ltd.
General Hospital · 61d
Cleared Feb 03, 2003
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 49d
Cleared Feb 03, 2003
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
K024355 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 35d
Cleared Feb 03, 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Feb 03, 2003
THERMACOOL TC SYSTEM
K030142 · GEI
Thermage, Inc.
General & Plastic Surgery · 19d
Cleared Jan 31, 2003
RADIOMED MARKER
K022326 · JAK
Radiomed Corporation
Radiology · 197d
Cleared Jan 31, 2003
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
K022596 · DQK
Clover Hi-Tech, Inc.
Cardiovascular · 179d