FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76441–76464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Jan 11, 2002
ACTAEON PROBE
K013429 · NGR
Osteobiologics, Inc.
Orthopedic · 87d
Cleared Jan 11, 2002
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K013462 · FRO
Hydrofera, LLC
General & Plastic Surgery · 85d
Cleared Jan 11, 2002
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M...
K013598 · DSA
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Jan 11, 2002
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
K014094 · HGM
Hill-Rom Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 11, 2002
MODIFICATION TO OUTBACK CATHETER
K014117 · DQY
Lumend, Inc.
Cardiovascular · 28d
Cleared Jan 11, 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118 · DQY
Abbott Vascular, Inc.
Cardiovascular · 28d
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