FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76945–76968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2002
INCARE ADVANCE
K013483 · KOD
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 14, 2002
KAVO POLYLUX II
K013500 · EBZ
Kavo America
Dental · 84d
Cleared Jan 14, 2002
84 CHANNEL EEG
K014146 · GWQ
Xltek
Neurology · 27d
Cleared Jan 14, 2002
80 CHANNEL EEG
K014147 · GWQ
Xltek
Neurology · 27d
Cleared Jan 14, 2002
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
K014205 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 24d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · FPD
Vygon Corp.
Gastroenterology & Urology · 445d
Cleared Jan 11, 2002
SMARTMONITOR 2, MODEL 4000
K011597 · FLS
Respironics Georgia, Inc.
Anesthesiology · 232d
Cleared Jan 11, 2002
RANDOX DIGITOXIN
K012112 · LFM
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared Jan 11, 2002
BODYFIX
K013391 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 88d
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