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
77569–77592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2002
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · DWJ
Nellcor Puritan Bennett, Inc.
Cardiovascular · 25d
Cleared Jan 10, 2002
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA...
K010033 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 371d
Cleared Jan 10, 2002
BODYGEM, MODEL HB211
K010577 · BZL
Healthetech, Inc.
Anesthesiology · 317d
Cleared Jan 10, 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM,...
K012075 · LGD
Diagnostic Products Corp.
Microbiology · 192d
Cleared Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2,...
K012077 · LFX
Diagnostic Products Corp.
Microbiology · 192d
Cleared Jan 10, 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745 · DKZ
Biosite Incorporated
Toxicology · 147d
Cleared Jan 10, 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · JBP
Helena Laboratories
Hematology · 118d
Cleared Jan 10, 2002
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
K013383 · DZE
Biomedical Implant Technology, Inc.
Dental · 90d
Cleared Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389 · OLW
Datex-Ohmeda
Neurology · 90d
Cleared Jan 10, 2002
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · GEI
Intuitive Surgical, Inc.
General & Plastic Surgery · 87d
Cleared Jan 10, 2002
MISONIX IRRIGATION SYSTEM MOEDL BC20P
K013417 · GBX
Misonix, Inc.
General & Plastic Surgery · 87d
Cleared Jan 10, 2002
DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
K013478 · DXN
Pulse Metric, Inc.
Cardiovascular · 83d
Cleared Jan 10, 2002
INFINITY EXPLORER
K013515 · DXJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 80d
Cleared Jan 10, 2002
VENTED VIAL ACCESS DEVICE
K013950 · FPA
Churchill Medical Systems, Inc.
General Hospital · 41d
Cleared Jan 10, 2002
MINIBLASTER
K013969 · KOJ
Deldent , Ltd.
Dental · 38d
Cleared Jan 10, 2002
GE LOGIQ 5
K014097 · IYN
GE Medical Systems
Radiology · 29d
Cleared Jan 10, 2002
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · DQK
General Electric Medical Systems...
Cardiovascular · 28d
Cleared Jan 10, 2002
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
K014250 · GCJ
Guidant Corp.
General & Plastic Surgery · 15d
Cleared Jan 09, 2002
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243 · KHJ
Bioform, Inc.
Ear, Nose, Throat · 103d
Cleared Jan 09, 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · KRO
Zimmer, Inc.
Orthopedic · 89d
Cleared Jan 09, 2002
POINT 4 TRANSLUCENT MODIFIED
K013529 · EBF
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Jan 09, 2002
EPOCA CODR STEM AND HEAD
K014049 · KWT
Stelkast Company
Orthopedic · 30d
Cleared Jan 08, 2002
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
K010933 · QSY
Alltracel Pharma , Ltd.
General & Plastic Surgery · 286d
Cleared Jan 08, 2002
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP...
K011190 · MUK
Surx, Inc.
Gastroenterology & Urology · 264d