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
84337–84360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K992872 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 90d
Cleared Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K992900 · JJY
Roche Diagnostics Corp.
Immunology · 86d
Cleared Nov 24, 1999
HYTAC
K992909 · EBF
Espe Dental AG
Dental · 86d
Cleared Nov 24, 1999
ENABLE ENDOSCOPIC BIPOLAR SCISSORS
K992996 · GEI
Enable Medical Corp.
General & Plastic Surgery · 78d
Cleared Nov 24, 1999
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC,...
K993071 · CBK
Puritan Bennett Corp.
Anesthesiology · 71d
Cleared Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV...
K993252 · MVN
CooperVision, Inc.
Ophthalmic · 57d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K993360 · JJY
Roche Diagnostics Corp.
Immunology · 49d
Cleared Nov 24, 1999
K-ASSAY C3
K993437 · CZW
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AG
K993441 · LKL
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AT
K993444 · DEM
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY HAPTOGLOBIN
K993480 · DAD
Kamiya Biomedical Co.
Immunology · 41d
Cleared Nov 24, 1999
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
K993495 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 40d
Cleared Nov 24, 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
K993502 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 40d
Cleared Nov 24, 1999
DIGITRAKPLUS HOLTER RECORDER
K993617 · MWJ
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
DXP1000 HOLTER RECORDER
K993618 · MWJ
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
K993637 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 27d
Cleared Nov 24, 1999
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K993648 · MCW
Boston Scientific Corporation...
Cardiovascular · 26d
Cleared Nov 24, 1999
CT PERFUSION OPTION
K993791 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 24, 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 23, 1999
EASY-JET DEVICE
K972383 · KLZ
A.Stein - Regulatory Affairs Consulting
Ear, Nose, Throat · 880d
Cleared Nov 23, 1999
TRENDCARE CALIBRATOR MODEL SCU 7007
K983198 · CCC
Diametrics Medical, Ltd.
Anesthesiology · 438d
Cleared Nov 23, 1999
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
K990512 · KRI
Stoeckert Instrumente
Cardiovascular · 278d
Cleared Nov 23, 1999
SIRSCAN
K991473 · KZK
Intelligence Artificielle Applications
Microbiology · 210d